U.S. patent application number 11/686121 was filed with the patent office on 2007-09-06 for phototherapy device and method of providing phototherapy to a body surface.
Invention is credited to John E. Crowe, James R. Flom, Michael Gertner, Norbert H. Leclerc, Brendan Jude Moran, Jonathan L. Podmore, Michael Rode, Erica Rogers.
Application Number | 20070208395 11/686121 |
Document ID | / |
Family ID | 38510268 |
Filed Date | 2007-09-06 |
United States Patent
Application |
20070208395 |
Kind Code |
A1 |
Leclerc; Norbert H. ; et
al. |
September 6, 2007 |
Phototherapy Device and Method of Providing Phototherapy to a Body
Surface
Abstract
A method and apparatus is described for treating a target body
surface using a radiation applicator. The therapeutic treatment
apparatus adapted to conform to a patients body. The treatment
apparatus comprises a plurality of light sources coupled with a
flexible substrate, a light integrator in at least a portion of the
optical path between the light source and the patient's body
surface, a power supply, and a controller.
Inventors: |
Leclerc; Norbert H.;
(Mountain View, CA) ; Moran; Brendan Jude;
(Redwood City, CA) ; Flom; James R.; (San Mateo,
CA) ; Gertner; Michael; (Menlo Park, CA) ;
Podmore; Jonathan L.; (San Carlos, CA) ; Rode;
Michael; (Sunnyvale, CA) ; Crowe; John E.;
(Menlo Park, CA) ; Rogers; Erica; (Redwood City,
CA) |
Correspondence
Address: |
WILSON SONSINI GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO
CA
94304-1050
US
|
Family ID: |
38510268 |
Appl. No.: |
11/686121 |
Filed: |
March 14, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11276787 |
Mar 14, 2006 |
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11686121 |
Mar 14, 2007 |
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11244812 |
Oct 5, 2005 |
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11276787 |
Mar 14, 2006 |
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60882439 |
Dec 28, 2006 |
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Current U.S.
Class: |
607/86 |
Current CPC
Class: |
A61B 2017/00026
20130101; A61N 2005/0652 20130101; A61N 5/062 20130101; A61B
2017/00057 20130101; A61B 2018/00642 20130101; A61N 2005/007
20130101; A61N 2005/0628 20130101; A61N 5/0616 20130101; A61B
2018/00702 20130101; A61B 2018/00785 20130101; A61N 2005/0645
20130101; A61N 2005/063 20130101 |
Class at
Publication: |
607/086 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. A therapeutic treatment apparatus adapted and configured to
conform to a target region of a patient, the apparatus comprising:
a plurality of light sources adapted and configured to couple to a
flexible substrate to deliver light to the target region, a power
supply coupled to the light sources and operable to provide power
to the light sources, and a controller coupled to the light sources
and the power supply and operable to control the operation of the
light sources, wherein the therapeutic treatment apparatus is
disposed adjacent a light integrator in at least a portion of an
optical path for the light between the light sources and the target
region of the patient during deployment.
2. The therapeutic treatment apparatus of claim 1 wherein each
light source further comprises one or more light emitting
diodes.
3. The therapeutic treatment apparatus of claim 1 wherein each
light source further comprises one or more laser diodes.
4. The therapeutic treatment apparatus of claim 2 or 3 wherein the
diode is positioned relative to a surface of the flexible substrate
to deliver light at one or more prescribed angles with respect to
the target region of the patient's body surface.
5. The therapeutic treatment apparatus of claim 1 wherein at least
one light sources emits light between wavelength range of 200-2,000
nm.
6. The therapeutic treatment apparatus of claim 1 wherein the
flexible substrate is a substrate consisting of rubber, cloth;
thermoplastic elastomer, thermoplastic, fabric, or flexible
metal.
7. The therapeutic treatment apparatus of claim 1 further
comprising a single-use layer positioned between light delivered by
the light sources and the target region of the patient's body
surface.
8. The therapeutic treatment apparatus of claim 1 wherein the light
integrator is formed from a rigid or semi-rigid material further
adapted and configured to at least partially transmit light.
9. The therapeutic treatment apparatus of claim 8 wherein the light
integrator is adapted and configured to internally reflect the
light to substantially uniformly distribute the light onto the
target region of the patient's body surface.
10. The therapeutic treatment apparatus of claim 8 wherein the
light integrator is adapted and configured to use a total internal
reflection to distribute the light onto the target region of the
patient's body surface.
11. The therapeutic treatment apparatus of claim 10 wherein the
internal reflection is substantially uniform.
12. The therapeutic treatment apparatus of claim 8 wherein one or
more lower edges of the light integrator are adapted and configured
to have a minimum radius of curvature of 0.5 mm and maximum radius
of curvature of 25 cm.
13. The therapeutic treatment apparatus of claim 8 wherein the
light integrator further comprises silicone rubber.
14. The therapeutic treatment apparatus of claim 1 wherein the
light integrator is at least partially further comprised of a
support structure adapted and configured to separate the light
sources and the target region of the patient's body surface.
15. The therapeutic treatment apparatus of claim 14 wherein the
support structure further comprises a partially reflective support
structure.
16. The therapeutic treatment apparatus of claim 14 wherein the
support structure is adapted and configured to contact <15% of
the target region of the patient's body surface.
17. The therapeutic treatment apparatus of claim 14 wherein the
light integrator further comprises a lens adapted and configured to
be positioned between the light source and the target region of the
patient's body surface.
18. The therapeutic treatment apparatus of claim 1 wherein the
substrate further comprises a substrate at least partially
transmissive to light.
19. The therapeutic treatment apparatus of claim 18 wherein the
substrate is silicone rubber.
20. The therapeutic treatment apparatus of claim 1 wherein the
controller is configurable to selectively control one or more
treatment parameters.
21. The therapeutic treatment apparatus of claim 1 wherein the
controller is configurable to selectively provide one or more
patient specific codes.
22. The therapeutic treatment apparatus of claim 1 wherein the
controller is configurable to selectively control one or more
treatment parameters for a specific target region of patient.
23. The therapeutic treatment apparatus of claim 1 wherein
apparatus further comprises sensors in communication with the
controller and configured to detect proper placement of the
apparatus on patient.
24. The therapeutic treatment apparatus of claim 20 wherein
treatment parameters are selected from the group consisting of:
duration of treatment, treatment frequency, or total numbers of
available treatments.
25. The therapeutic treatment apparatus of claim 1 wherein the
apparatus further comprises an attachment mechanism adapted and
configured to attach the apparatus to the patient.
26. The therapeutic treatment apparatus of claim 25 wherein the
attachment mechanism is selected from the group consisting of:
adhesive, straps, material wraps, or a cuff.
27. The therapeutic treatment apparatus of claim 1 wherein the
apparatus further comprises a heat collector adapted and configured
to absorb heat generated by the light sources.
28. The therapeutic treatment apparatus of claim 27 wherein the
heat collector further comprises a material integrated with each
light source wherein the material is selected from the group
consisting of a heat conductive material or a heat absorbing
material.
29. The therapeutic treatment apparatus of claim 1 wherein the
apparatus further comprises a targeting mask adapted and configured
to at least partially block therapeutic light from a first region
of a patient and at least partially transmit therapeutic light to a
second region of a patient.
30. The therapeutic treatment apparatus of claim 29 wherein the
targeting mask further comprises an attachment mechanism adapted
and configured to attach the apparatus to the patient.
31. The therapeutic treatment apparatus of claim 30 wherein the
attachment mechanism further comprises adhesive.
32. The therapeutic treatment apparatus of claim 29 wherein the
mask further comprises at least one flexible material.
33. The therapeutic treatment apparatus of claim 32 wherein the
flexible material is selected from the group consisting of foam,
rubber, plastic, synthetic fabric, natural fabric, or
elastomer.
34. A therapeutic treatment apparatus adapted and configured to
contact a target surface of a patient comprising: a light source, a
power supply coupled to the light source and operable to provide
power to the light source, a power switch coupled to the light
source and the power supply and operable to control delivery of
power from the power supply to the light source, and a light
integrator adapted and configured to selectively transmit light
from the light source to a target surface.
35. A therapeutic treatment apparatus adapted and configured to
conform to a surface of a patient comprising: a plurality of light
sources flexibly interconnected to at least one other light source,
a power supply coupled to the light sources and operable to provide
power to the light sources, a controller coupled to the light
sources and the power supply and operable to control the operation
of the light sources, wherein each light source further comprises
an optical waveguide adapted and configured to selectively
distribute light onto the target surface.
36. The therapeutic treatment apparatus of claim 35 wherein the
waveguide further comprises silicone rubber.
37. The therapeutic treatment apparatus of claim 35 wherein the
waveguide further comprises optical fibers.
38. A therapeutic treatment apparatus adapted and configured to
conform to a patient comprising: a plurality of light sources
adapted and configured to deliver light wherein the light sources
are coupled to an elastomeric substrate and further wherein the
substrate is comprised of a material having a durometer of less
than or equal to shore 70 A and is at least partially transmissive
to the light, a power supply coupled to the light sources and
operable to provide power to the light sources, and a controller
coupled to the light sources and the power supply wherein the
controller is operable to control the operation of the light
sources.
39. A therapeutic treatment apparatus adapted and configured to
conform to a target surface of a patient comprising: a plurality of
light sources, a power supply coupled to the light sources and
operable to provide power to the light sources, a controller
coupled to the light sources and the power supply and operable to
control the operation of the light sources, wherein the light
sources are flexibly connected and further wherein the distance
between at least two of the light sources is less than or equal to
the distance between light sources and the target surface.
40. A therapeutic treatment apparatus system comprising: a light
source, a controller coupled to the light source, a power supply
coupled to the light source and the controller and operable to
provide power to the system, a fiber optic fiber adapted and
configured to deliver light from the light source to a flexible
substrate adapted and configured to conform to a patient's body
surface, wherein the fiber optic fibers terminate into a light
integrator which substantially uniformly distributes light onto
target surface.
41. A therapeutic treatment apparatus adapted and configured to
conform to a target region of a patient comprising: a plurality of
light sources coupled to a flexible substrate, a power supply
coupled to the light sources and operable to provide power to the
light sources, a controller coupled to the light sources and the
power supply and operable to control the operation of the light
sources, and a light integrator adapted and configured to be
positioned in at least a portion of an optical pathway between the
light source and the target region of the patient, wherein the
light sources are spaced such that D=2 {square root over
(2dR-d.sup.2)} where D is a width of light integrator, R is a
radius of curvature of the target region, and d is a sum of tissue
compression and an optically allowable gap between the light
integrator and a target region.
42. A therapeutic treatment apparatus adapted and configured to
conform to a patient's body comprising: a plurality of light
sources, a power supply coupled to the light sources and operable
to provide power to the light sources, and a controller coupled to
the light sources and the power supply and operable to control the
operation of the light sources, wherein the light sources are
adapted and configured to illuminate such that the light exiting
the light source is substantially parallel with the body.
43. A method of treating a prescribed area of a target body surface
comprising the steps of: (a) applying a light therapy device
adapted to conform to the target body surface; and (b) selectively
delivering a therapeutic dose of light to at least a portion of the
target body surface.
44. The method of claim 43 where the method provides treatment for
a clinical indication selected from the group consisting of: (a)
psoriasis (b) vitiligo (c) atopic dermatitis (d) infection (e) sun
tanning (f) acne (g) skin cancer (h) actinic ketatosis (i) hair
removal (j) dermal vascular lesions or pigmentation (k) skin
rejuvenation (l) bilirubin
45. The method of claim 43 further comprising chilling a device
prior to applying light therapy device to a body surface.
46. A method of treating a prescribed area of a target body surface
comprising the steps of: (a) administering a photosensitizer to a
patient; (b) applying a light therapy device adapted and configured
to conform to the target body surface; and (c) delivering a
therapeutic dose of light to at least a portion of the target body
surface.
47. A method of treating a prescribed area of a target body surface
comprising the steps of: (a) applying a light therapy device
adapted to conform to the target body surface and comprising a
plurality of light sources; (b) using a detector to determine at
least one property of target tissue; and (c) selectively activating
one or more of the light sources in response to the detector to
deliver a therapeutic dose of light to the target tissue.
48. The method of claim 47 further comprising the step of detecting
one or more of the following properties: temperature, electrical
impedance, photoreflectance, thickness, hardness, moisture,
acoustic reflections.
49. The method of claim 48 wherein the step of measuring photo
reflectance includes the step of measuring one or more of:
roughness, color, or fluorescence.
50. A method of treating a prescribed area of a target body surface
comprising the steps of: (a) applying a targeting mask to the
target body surface; (b) applying a light therapy device adapted
and configured to conform to the target body surface and at least
partially coupled to the targeting mask; and (c) delivering a
therapeutic dose of light to at least a portion of the target body
surface through the targeting mask.
51. A method of treating a prescribed area of a target body surface
comprising the steps of: (a) applying a substance to a
non-prescribed region of a body surface which at least partially
blocks therapeutic light; (b) applying a light therapy device
adapted and configured to conform to the target body surface to a
prescribed region of the body surface and at least partially to the
non-prescribed region; (c) delivering a therapeutic dose of light
to at least a portion of the prescribed region.
52. The method of claim 51 where the light blocking substance is
one of a cream, lotion, gel, ointment, paste, or fluid.
Description
CROSS-REFERENCE
[0001] This application is a continuation-in-part application of
Ser. No. 11/276,787 filed Mar. 14, 2006, which in turn is a
continuation-in-part application of Ser. No. 11/244,812, filed Oct.
5, 2005, which are incorporated herein by reference in their
entirety and to which application priority is claimed under 35
U.S.C. .sctn.120. This application also claims benefit of U.S.
Provisional Application No. 60/882,439 filed Dec. 28, 2006, which
is also incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to devices and methods of use for
small, portable devices adapted and configured to deliver
phototherapeutic treatments to a select area of a skin surface to
treat medical skin disorders or to perform cosmetic dermatological
therapies. More specifically, the devices comprise a plurality of
light sources and are flexible such that the devices are adapted to
conform to a body surface while providing controlled light
distribution.
[0004] 2. Background of the Invention
[0005] The therapeutic use of light has been shown to be effective
in the treatment of various medical conditions. For example,
ultraviolet ("UV") light has been used for medical applications,
such as the treatment of psoriasis, atopic dermatitis and vitiligo.
Ultraviolet lasers and lamps with UVB light are currently used for
treating these conditions. In some cases, PUVA, combining UVA light
with psoralen, is used to treat psoriasis. Treatment typically
requires a patient visiting their physician approximately 3 visits
per week for up to 16 weeks. Photodynamic therapy (PDT) is a
recently evolving modality for the treatment of skin conditions
such as actinic keratosis, acne, and skin cancer. This treatment
involves the use of light, including red light, with a
photosensitizer. The photosensitizer is either administered orally
or topically.
[0006] It has been shown that UVC light in approximately 254 nm
wavelength can sterilize microorganisms including, but not limited
to, viruses and bacteria. Skin infections, then, can be treated
with UVC light. Some infections, including Staph. Aureus, are
resistant to most antibiotics. Even these resistant microorganisms
can be sterilized with UVC light. However, there are no small,
portable devices currently available to deliver this type of
treatment.
[0007] Phototherapy is also used for certain cosmetic
dermatological conditions. Procedures to remove unwanted hair,
remove vascular lesions or pigmentation, eliminate acne, and
rejuvenate the skin, for example, are becoming common. These
treatments typically use light in either visible wavelengths
(400-800 nm) or near infrared and infrared wavelengths (800-2000
nm). Common devices for these treatments are lasers; however, other
light sources, including LED's, are also available for certain of
these treatments like acne. These treatments also typically require
a series of visits to a physician's office. Skin tanning is another
cosmetic procedure using light, typically UVA. Tanning beds with
bulbs which can illuminate a large body surface area are commonly
used for this purpose.
[0008] Phototherapy has proven to be a viable and desirable
treatment strategy for the above mentioned skin ailments and
cosmetic procedures. However, current phototherapy treatment
available to patients has several shortcomings. In one treatment
strategy for psoriasis, patients must visit a physician office and
sit unclothed in a phototherapy chamber for a period of time. In
this type of treatment, areas of healthy skin are also exposed to
the treatment dose which may cumulatively lead to damage to skin
that was originally normal and healthy. Additionally, this
treatment requires numerous visits to a physician office to receive
a course of therapy. The expense and loss of productivity due to
these visits is a compelling reason for the advent of a new
technology. Additionally, lasers and bulb light sources are
undesirably large. In a clinic, they reduce available space for
other medical equipment. Additionally, these light sources can be
prohibitively expensive.
[0009] An alternative therapeutic device that is small, portable,
and meets or exceeds the therapeutic benefit provided by the above
devices is hereby described. In order to provide therapeutic
benefit, the light distribution of the device must be selectively
controlled. Additionally, a suitable device or mechanism to treat
only the target region of skin is desirable.
[0010] A variety of devices are known for delivering light and/or
radiation. For example, PCT Publication WO 2005/000389 to Fiset for
Skin Tanning and Light Therapy Incorporating Light Emitting Diodes
(see also, U.S. Patent Pub. 2004/0232339 to Lanoue for
Hyperspectral Imaging Workstation Having Visible/Near-Infrared and
Ultraviolet Image Sensors). U.S. Pat. No. 6,290,713 to Russell for
Flexible Illuminators for Phototherapy; U.S. Patent Pub.
2004/0176824 to Weckworth for Method and Apparatus for the
Repigmentation of Human Skin; U.S. Pat. No. 6,730,113 to Eckhardt
et al. for Method and Apparatus for Sterilizing or Disinfecting A
Region Through a Bandage; U.S. Pat. No. 6,096,066 to Chen et al.
for Conformal Patch for Administering Light Therapy to Subcutaneous
Tumors; and U.S. Pat. No. 6,645,230 to Whitehurst for Therapeutic
Light Source and Method. A variety of devices are also known for
providing bandages or dressing, including, for example, U.S. Pat.
No. 2,992,644 to Plantinga et al. for Dressing; U.S. Pat. No.
3,416,525 to Yeremian for Stabilized Non-Adherent Dressing; U.S.
Pat. No. 3,927,669 to Glatt for Bandage Construction; U.S. Pat. No.
4,126,130 to Cowden for Wound Protective Device; U.S. Pat. No.
4,561,435 to McKnight et al. for Wound Dressing; U.S. Pat. No.
4,616,644 to Saferstein et al. for Hemostatic Adhesive Bandage;
U.S. Pat. No. 4,671,266 to Lengyel et al. for Blister Bandage; U.S.
Pat. No. 4,901,714 to Jensen for Bandage; U.S. Pat. No. 5,336,209
to Porilli for Multi-Function Wound Protection Bandage and Medicant
Delivery System with Simultaneous Variable Oxygenation; U.S. Pat.
No. 5,954,679 to Baranitsky for Adhesive Bandage; 6,096,066 to Chen
for Conformal Patch for Administering Light Therapy to Subcutaneous
Tumors; U.S. Pat. No. 6,343,604 B1 to Beall for Protective Non
Occlusive Wound Shield; U.S. Pat. No. 6,384,294 B1 to Levin for
Protective Bandages Including Force-Transmission-Impeding Members
Thereof; U.S. Pat. No. 6,443,978 to Zharov for Photomatrix Device;
U.S. Pat. No. 5,616,140 to Prescott for Method and Apparatus for
Therapeutic Laser Treatment; U.S. Pat. No. 5,913,883 to Alexander
et al for Therapeutic Facial Mask; U.S. Pat. No. 6,866,678 to
Shenderova et al. for Phototherapeutic Treatment Methods and
Apparatus; U.S. Pat. No. 6,986,782 to Chen et al. for Ambulatory
Photodynamic Therapy; U.S. Pat. No. 6,955,684 to Savage Jr., et
al., for Portable Light Delivery Apparatus and Methods; and U.S.
Patent Publications US 2001/0028943 A1 to Mashiko et al. for
Adhesive Film for Adhesive Bandage Using Said Adhesive Film; US
2002/0128580 A1 to Carlson for Self-Adhering Friction Reducing
Liner and Method of Use; US 2002/0183813 A1 to Augustine et al. for
Treatment Apparatus with a Heater Adhesively Joined to the Bandage;
US 2003/0199800 A1 to Levin for Bandage Including Perforated Gel;
US 2003/0163074 A1 to McGowan et al. for Wound Dressing Impervious
to Chemical and Biological Agents; US 2003/0143264 A1 to Margiotta
for Topical Anesthetic-Antiseptic Patch; US 2004/0087884 A1 to
Haddock et al. for Textured Breathable Films and Their Use as
Backing Material for Bandages; US 2004/0049144 A1 to Cea for
Hypoallergenic Bandage; US 2004/0260365 to Groseth et al. for
Photodynamic Therapy Lamp; and US 2005/0010154 A1 to Wright et al.
for Adhesive Bandage for Protection of Skin Surface.
SUMMARY OF THE INVENTION
[0011] The invention relates to a photodynamic or radiation
treatment apparatus having a light and/or radiation source adapted
to irradiate a target portion of a body.
[0012] Provided is a device to deliver phototherapy and
photodynamic therapy in a spatially uniform dose to an area of a
body surface in need. The phototherapy treatment includes
ultraviolet, visible, and infrared light as is necessitated by the
specific condition to be treated. This device is specifically
designed and constructed to conform to an arbitrary body surface to
optimize the therapeutic options for a patient. For example, an
embodiment of the described device has configurable flexibility to
provide phototherapy to the face, back, knee, and elbow in separate
instances without substantially changing in form or general
functionality.
[0013] In accordance with the invention, therapeutic light is
generated by small, lightweight light sources such as LEDs or
lasers and delivered via a flexible, conformal optically
transmissive element to a body surface. It is intended that this
element make direct, intimate contact with a body surface. The
element is both thin in profile and made at least in part from a
soft, flexible material thus engendering its conformal nature.
[0014] Still further in accordance with the described invention,
the device is intended to be securely attached to a patient via an
adhesive, a strap, or other mechanism such that the recipient of
the therapy is minimally encumbered during treatment. Additionally,
light sources are controlled by a small microprocessor and powered
by a battery. The combination of the preceding two qualities
enables the patient to, for example, be free to move about during
treatment.
[0015] Still further in accordance with the described invention,
the light delivery element is in part composed of rigid or
semi-rigid optical integrator elements that are in intimate contact
with the body surface and adhered to a flexible substrate. One or
more light sources are associated with each of these optical
integrator elements. The optical transmission properties of each
integrator element are such that a uniform light distribution is
transmitted to the body surface in which it is in contact. The
spacing and configuration geometry of the light integrator elements
essentially determine the total body surface area receiving
treatment. Therefore, the ensemble effect of such elements on a
flexible substrate is to substantially conform to a body surface as
well as deliver a uniform therapeutic treatment over the same
surface.
[0016] Still further in accordance with the described invention is
an intermediary targeting mask to be used in concert with the
phototherapy delivery element. This targeting mask is used in
regions where an affected area is irregular in shape and overall
smaller in size as compared to the therapy device. Its function is
to be placed in between the device and the body surface and
selectively expose affected surface areas to the phototherapy
treatment while simultaneously minimizing or eliminating such a
treatment light from reaching unaffected neighboring regions of
healthy skin surface. Still further in accordance with the
described invention is the ability to detect the zone for treatment
and subsequently power a subset of the light sources on the
phototherapy delivery element.
[0017] Further aspects, details, and embodiments of the present
invention will be understood by those of skill in the art upon
reading the following detailed description of the invention and the
accompanying drawings.
[0018] An aspect of the invention is directed to a therapeutic
treatment apparatus adapted and configured to conform to a target
region of a patient. An apparatus according to this embodiment
includes, a plurality of light sources adapted and configured to
couple to a flexible substrate to deliver light to the target
region, a power supply coupled to the light sources and operable to
provide power to the light sources, and a controller coupled to the
light sources and the power supply and operable to control the
operation of the light sources, wherein the therapeutic treatment
apparatus is disposed adjacent a light integrator in at least a
portion of an optical path for the light between the light sources
and the target region of the patient during deployment.
[0019] The apparatus or devices of the invention can further be
adapted such that each light source further comprises one or more
light emitting diodes or one or more laser diodes. Diodes can be
positioned relative to a surface of the flexible substrate to
deliver light at one or more prescribed angles with respect to the
target region of the patient's body surface. A variety of
wavelengths are suitable for the invention, including, for example,
wavelengths in the range of 200-2000 nm. Flexible substrates can be
formed from any suitable material that achieves the conformable
aspect, including, for example, rubber, cloth; thermoplastic
elastomer, thermoplastic, fabric, or flexible metal. Furthermore,
the devices can further include a single-use layer positioned
between light delivered by the light sources and the target region
of the patient's body surface. Additionally, the light integrator
can be formed from a rigid or semi-rigid material further adapted
and configured to at least partially transmit light. The light
integrator facilitates and integrates the transmission of light to
the target area. For example, the light integrator can be adapted
and configured to internally reflect the light to substantially
uniformly distribute the light onto the target region of the
patient's body surface or adapted and configured to use a total
internal reflection to distribute the light onto the target region
of the patient's body surface, such as where the internal
reflection is substantially uniform. Additionally, one or more
lower edges of the light integrator can further be adapted and
configured to have a minimum radius of curvature of 0.5 mm and
maximum radius of curvature of 25 cm. In some embodiments, it may
be desirable to form the light integrator from silicone rubber. The
light integrator in some embodiments, is at least partially further
comprised of a support structure adapted and configured to separate
the light sources and the target region of the patient's body
surface. A suitable support structure can further be partially
reflective and/or be adapted and configured to contact <15% of
the target region of the patient's body surface.
[0020] Light integrators used with the therapeutic treatment
apparatus can further comprise a lens adapted and configured to be
positioned between the light source and the target region of the
patient's body surface. Additionally, the substrates can further
comprises a substrate at least partially transmissive to light,
such as silicone rubber. A variety of controllers are suitable for
use with the invention. The controllers can use a shared power
source as the light sources, or an independent power source. The
controllers can further be configurable to selectively control one
or more treatment parameters, such as for a specific region of the
patient, and/or to provide one or more patient specific codes.
Treatment parameters can include, for example, duration of
treatment, treatment frequency, or total numbers of available
treatments.
[0021] A variety of sensors can be provided in conjunction with the
apparatus. The sensors can be configured to detect, for example,
proper placement of the apparatus on patient.
[0022] Depending upon the target region to be treated, the
apparatus may further be configured to provide an attachment
mechanism in order to faclitate deployment of the device onto the
patient's target region. The attachment mechanism can include, for
example, the use of adhesives or adhesive sections, straps,
material or fabric wraps, or a cuff.
[0023] An additional feature of the apparatus can include a heat
collector adapted and configured to absorb heat generated by the
light sources. The heat collector can further comprise, for
example, a material, such as a heat absorbing material or a heat
conductive material, integrated with each light source. Integrating
a heat absorber or heat conducter facilitates drawing at least some
of the heat away from the surface of the skin.
[0024] In still another embodiment of the invention, a targeting
mask adapted and configured to at least partially block therapeutic
light from a first region of a patient (e.g., healthy skin that
does not require treatment) and at least partially transmit
therapeutic light to a second region of a patient (e.g., skin
having a lesion to be treated) is provided. The targeting mask can
be configured to integrate with the apparatus or can further
comprise its own an attachment mechanism, such as adhesive, adapted
and configured to attach the targeting mask to the patient.
Typically, the mask will be comprised of at least one flexible
material, such as foam, rubber, plastic, synthetic fabric, natural
fabric, or elastomer, to facilitate placement on a patient.
[0025] In another aspect of the invention, a therapeutic treatment
apparatus is provided that is adapted and configured to contact a
target surface of a patient. The apparatus comprising: a light
source, a power supply coupled to the light source and operable to
provide power to the light source, a power switch coupled to the
light source and the power supply and operable to control delivery
of power from the power supply to the light source, and a light
integrator adapted and configured to selectively transmit light
from the light source to a target surface.
[0026] In still another aspect of the invention, a therapeutic
treatment apparatus adapted and configured to conform to a surface
of a patient is provided. The apparatus, or device, comprises a
plurality of light sources flexibly interconnected to at least one
other light source, a power supply coupled to the light sources and
operable to provide power to the light sources, a controller
coupled to the light sources and the power supply and operable to
control the operation of the light sources, wherein each light
source further comprises an optical waveguide adapted and
configured to selectively distribute light onto the target surface.
The waveguide can, in turn, be comprised completely or partially of
silicone rubber. Additionally, the waveguide can further comprise
one or more optical fibers.
[0027] In yet another aspect of the invention, a therapeutic
treatment apparatus is provided that is adapted and configured to
conform to a patient. The apparatus comprises a plurality of light
sources adapted and configured to deliver light wherein the light
sources are coupled to an elastomeric substrate and further wherein
the substrate is comprised of a material having a durometer of less
than or equal to shore 70 A and is at least partially transmissive
to the light, a power supply coupled to the light sources and
operable to provide power to the light sources, and a controller
coupled to the light sources and the power supply wherein the
controller is operable to control the operation of the light
sources.
[0028] Another aspect of the invention is directed to a therapeutic
treatment apparatus adapted and configured to conform to a target
surface of a patient comprising: a plurality of light sources, a
power supply coupled to the light sources and operable to provide
power to the light sources, a controller coupled to the light
sources and the power supply and operable to control the operation
of the light sources, wherein the light sources are flexibly
connected and further wherein the distance between at least two of
the light sources is less than or equal to the distance between
light sources and the target surface.
[0029] Yet another aspect of the invention includes a therapeutic
treatment apparatus system comprising: a light source, a controller
coupled to the light source, a power supply coupled to the light
source and the controller and operable to provide power to the
system, a fiber optic fiber adapted and configured to deliver light
from the light source to a flexible substrate adapted and
configured to conform to a patient's body surface, wherein the
fiber optic fibers terminate into a light integrator which
substantially uniformly distributes light onto target surface.
[0030] Still another aspect of the invention includes a therapeutic
treatment apparatus adapted and configured to conform to a target
region of a patient comprising: a plurality of light sources
coupled to a flexible substrate, a power supply coupled to the
light sources and operable to provide power to the light sources, a
controller coupled to the light sources and the power supply and
operable to control the operation of the light sources, and a light
integrator adapted and configured to be positioned in at least a
portion of an optical pathway between the light source and the
target region of the patient, wherein the light sources are spaced
such that D=2 {square root over (2dR-d.sup.2)} where D is a width
of light integrator, R is a radius of curvature of the target
region, and d is a sum of tissue compression and an optically
allowable gap between the light integrator and a target region.
[0031] Yet another aspect is directed to a therapeutic treatment
apparatus adapted and configured to conform to a patient's body
comprising: a plurality of light sources, a power supply coupled to
the light sources and operable to provide power to the light
sources, and a controller coupled to the light sources and the
power supply and operable to control the operation of the light
sources, wherein the light sources are adapted and configured to
illuminate such that the light exiting the light source is
substantially parallel with the body.
[0032] The invention also contemplates a method of treating a
prescribed area of a target body surface. The method generally
comprises the steps of applying a light therapy device adapted to
conform to the target body surface; and selectively delivering a
therapeutic dose of light to at least a portion of the target body
surface. The method is suitable for treatment of clinical
indications identified by a healthcare practitioner, such as
psoriasis, vitiligo, atopic dermatitis, infection, sun tanning,
acne, skin cancer, actinic keratosis, hair removal, dermal vascular
lesions or pigmentation, skin rejuvenation, and bilirubin. As will
be appreciated by those skilled in the art, these devices can be
chilled prior to applying light therapy to a body, or during the
delivery of light therapy.
[0033] Still another method contemplated is a method of treating a
prescribed area of a target body surface comprising the steps of:
administering a photosensitizer to a patient; applying a light
therapy device adapted and configured to conform to the target body
surface; and delivering a therapeutic dose of light to at least a
portion of the target body surface.
[0034] Yet another method is directed to a method of treating a
prescribed area of a target body surface comprising the steps of:
applying a light therapy device adapted to conform to the target
body surface and comprising a plurality of light sources; using a
detector to determine at least one property of target tissue; and
selectively activating one or more of the light sources in response
to the detector to deliver a therapeutic dose of light to the
target tissue. Additionally, the step of detecting can include
detecting, for example, temperature, electrical impedance,
photoreflectance, thickness, hardness, moisture, acoustic
reflections. Additionally, measuring photo reflectance can include
measuring one or more of: roughness, color, or fluorescence.
[0035] Another method of treating a prescribed area of a target
body surface is provided that comprises the steps of: applying a
targeting mask to the target body surface; applying a light therapy
device adapted and configured to conform to the target body surface
and at least partially coupled to the targeting mask; and
delivering a therapeutic dose of light to at least a portion of the
target body surface through the targeting mask.
[0036] Still another method of treating a prescribed area of a
target body surface is provided that comprises the steps of:
applying a substance to a non-prescribed region of a body surface
which at least partially blocks therapeutic light; applying a light
therapy device adapted and configured to conform to the target body
surface to a prescribed region of the body surface and at least
partially to the non-prescribed region; delivering a therapeutic
dose of light to at least a portion of the prescribed region. As
will be appreciated by those skilled in the art, light blocking
substance can be, for example, cream, lotion, gel, ointment, paste,
or fluid.
INCORPORATION BY REFERENCE
[0037] All publications, patents and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0039] FIG. 1 illustrates an example of a radiation applicator for
applying radiation to a target surface;
[0040] FIG. 2A illustrates an example of target surface of a body
being treated using the radiation applicator of FIG. 1;
[0041] FIG. 2B illustrates a cross-sectional view of a target
surface of a body being treated using the radiation applicator of
FIG. 1;
[0042] FIG. 3 illustrates a block diagram of an example of the
radiation applicator of FIG. 1;
[0043] FIG. 4 illustrates a block diagram of a controller;
[0044] FIG. 5A shows a block diagram of an example of a radiation
source used in FIGS. 1-3; FIG. 5B illustrates a cross section of a
radiation applicator of FIG. 3; FIG. 5C illustrates another example
of a radiation source of FIG. 1; FIG. 5D is a close-up of a molded
covering with optical components built in; and FIG. 5E is a
close-up of a mount with three-dimensional geometries optimized for
radiation extraction from the source.
[0045] FIG. 6A illustrates yet another example of a radiation
applicator; FIG. 6B illustrates an example of a cross-section of
the radiation applicator of FIG. 6A; FIG. 6C illustrates a
radiation applicator delivering radiation therapy to a prescribed
surface area within a target body surface;
[0046] FIG. 7A illustrates a wearable optical therapy device in the
form of a wrist bracelet; FIG. 7B illustrates an optical therapy
device in the form of an adhesive bandage;
[0047] FIGS. 8A-B illustrates a planar light source that provides a
uniform intensity of light;
[0048] FIG. 9 illustrates any of the embodiments of the invention
adapted and configured to be placed on a target portion of a human
body;
[0049] FIGS. 10A-C illustrates a flexible conformable light
delivery device;
[0050] FIG. 11 illustrates depicts a cross-section of an embodiment
of a flexible, conformable light delivery device according to the
invention;
[0051] FIGS. 12A-B illustrate cross-sectional view of an
interfacial feature between a plane of contact and a conformable,
flexible light delivery device;
[0052] FIGS. 13A-B illustrate an embodiment of the invention where
each light source is associated with an individual geometric
region;
[0053] FIGS. 14A-C illustrate the building blocks of a geometric
region;
[0054] FIGS. 15A-C illustrate schematic plan view of embodiments of
single cell geometry;
[0055] FIG. 16 is a schematic representation of a design rule that
illustrates a relationship of various design components for
embodiments of the invention;
[0056] FIGS. 17A-E illustrate various views of an embodiment of the
invention;
[0057] FIG. 18A-B illustrate a light source associated with a
housing;
[0058] FIGS. 19A-B illustrate variations of a light housing, light
source element;
[0059] FIGS. 20A-B illustrate an exploded view of a view according
to the invention, and the configured device;
[0060] FIGS. 21A-C illustrate a masking element;
[0061] FIG. 22 illustrates an alternative embodiment of a device
for delivering targeted phototherapy;
[0062] FIG. 23; depicts a detailed view of a module which is
insertable into a radiation applicator;
[0063] FIG. 24 depicts a schematic view of several component
elements in an example computer simulation of an optical intensity
distribution.
[0064] FIG. 25A-B depicts the resultant intensity profiles
calculated in the example simulation.
DETAILED DESCRIPTION OF THE INVENTION
[0065] A radiation applicator used for irradiating a target portion
of a body for medical treatment is disclosed. In an embodiment,
radiation delivered by a radiation applicator is ultraviolet light.
In other embodiments, other forms of radiation may be delivered by
the radiation applicator.
[0066] FIG. 1 shows a radiation applicator 100 for treating a
target surface of a body with radiation. As will be appreciated by
those skilled in the art, the target surface of a body includes the
portion of a body surface onto which a radiation applicator is
applied when the device is deployed for use on the target surface
of the patient's body. At least a portion of the target body
surface will include an area to which radiation therapy will be
applied, such as a lesion. The portion of the target body surface
to which radiation therapy is applied can, for example, be referred
to as the therapeutic surface area or the prescribed surface area.
As will further be appreciated by those of skill in the art, the
therapeutic surface area can be of a size and shape that may or may
not be conformable with the size and shape of the area comprising
the target body surface. Thus, the size and shape of both the
therapeutic or prescribed surface area can be the same, or
substantially the same, as the size and shape of the target body
surface. Alternatively, the size and shape of the therapeutic or
prescribed surface area can be smaller or larger than the target
body surface, without departing from the scope of the
invention.
[0067] The radiation applicator 100 has at least a first side and a
second side, or a top side and a bottom side with one side applied
to the target body surface while the other side, typically, is not.
The target surface is typically an exposed portion or surface, e.g.
of skin, where it is desirable to apply radiation. Radiation
applicator 100 may include one or more radiation source(s) 102
(e.g. 102a-102n) each of which has at least a first side and a
second side, and substrate 104, also having a first side and a
second side, which can be in the form of a layer or material on
which the electrodes are formed or fabricated. In a preferred
embodiment a plurality of radiation sources 102 are provided.
Radiation sources refers to the actual source of the radiation and
can also include structural elements associated with the source of
energy which allow the radiation source to be manipulated
independently of the substrates and other radiation sources. For
example, (as discussed below) in the case where the radiation
source is a light source, radiation source 102 can include a
header, electrodes, reflecting features, focusing features, mounts
with circuits and/or heat transferring features included thereon,
and submounts. In further embodiments, the radiation applicator 100
has a delivery region 106 that has a surface area smaller than the
surface area of the substrate 104 (as illustrated in FIG. 3). As
will be appreciated by those skilled in the art, radiation
applicator 100 need not have all of the components depicted in FIG.
1 and/or may include other components in addition to or instead of
those depicted with FIG. 1. For purposes of illustration, the
geometric profile of the radiation applicator 100 has been shown as
having a rectangular profile (e.g. a length greater than a width).
As will be appreciated by those skilled in the art, other profiles
can be employed, either geometric or non-geometric (e.g., random)
without departing from the scope of the invention. The various
layers and elements of the applicator 100 can be configured such
that each provides a surface-to-surface contact with an adjacent
layer and/or element.
[0068] Radiation source(s) 102 may produce any of a variety of
types of radiation, such as UV light, white light, and/or infrared
light that are used for treating disorders, ailments or diseases by
irradiating a target portion of the body, such as an exposed
surface of skin. A variety of dermatologic conditions, such as
psoriasis, contact dermatitis, atopic dermatitis, vitiligo,
seborrheic dermatosis, acne, cellulite, unwanted hair, unwanted
blood vessels, and skin cancer, may be treated with various
wavelengths of light, as discussed above. For example, when
treating psoriasis, radiation source(s) 102 may emit light having a
wavelength in the UVB range, including 295-320 nm, 300-305 nm,
308-315 nm, or a combination of these wavelengths in one or more
peaks. When treating psoriasis with psoralen (PUVA), it is
desirable to use radiation sources which emit light in the UVA
range, for example, between 320 nm and 340 nm, between 341 nm and
360 nm, and/or between 361 nm and 390 nm. Additionally, there may
be any number of radiation source(s) 102 with any combination of
wavelengths.
[0069] It may be desirable to provide radiation source(s) that are
capable of delivering more than one type of radiation. For example,
atopic dermatitis can be treated with a device using, for example,
a combination of UVB and UVA wavelengths. Thus, alternatively, it
may be desirable to provide radiation source(s) 102 within the
substrate 104 that can deliver a first radiation type or wavelength
in combination with radiation source(s) 102 that can deliver a
second, or subsequent, radiation type or value that is different
from the first radiation type or wavelength. As will be appreciated
by those of skill in the art, additional wavelengths or sources of
radiation can be included without departing from the scope of the
invention, and thus the invention is not limited to the delivery of
two radiation types.
[0070] Infectious disorders can also be treated with the radiation
source(s). For example, where infectious disorders are treated,
shorter wavelengths, including those having a wavelengths in the
range 254-270 nm or 270-295 nm, have been shown to be beneficial.
As will be appreciated, the various dashed lines between various
ones of radiation source(s) 102 (e.g. 102a-102n) indicate that
there may be any number of radiation source(s) in that location
spanning the region of the dashed lines and the region between the
dashed lines, as necessary or desirable.
[0071] In another embodiment, radiation source(s) 102 (e.g.
102a-102n) produce white light (500-750 nm), infrared light,
microwaves, radiofrequency radiation, and/or other electromagnetic
wavelengths, for example, or combinations thereof. Heat (via
infrared light) sometimes promotes healing of sprains and muscle
injuries, and additionally may produce a feeling of well-being,
even if no actual healing occurs. Infrared wavelengths include
wavelengths from 780 run to 10 microns. Infrared light can also be
used to aid in healing of open surface wounds on a body or to
increase the blood flow to a body surface. In some embodiments, the
infrared light can be used to increase local blood flow to a body
surface in order to improve the efficacy of phototherapy or
photodynamic therapy. In some embodiments, infrared light can be
used to destroy hair follicles which results in permanent or
semi-permanent hair removal; cellulite can also be treated with
infrared wavelengths. Other wavelengths of light in the mid-visible
range (e.g. about 500-650 nm) can be used to treat acne, wrinkles,
or other undesirable spots; white light wavelengths can also be
used for photorejuvenation and/or cellulite removal. Some
wavelengths of light (e.g. those having a wavelength of 450-460 nm)
may be effective in treating different disorders, such as for
lowering the bilirubin count in babies. In one embodiment,
radiation source(s) 102 are used for treating disorders on a
surface of a body. In another embodiment, radiation source(s) 102
emit forms of radiation (e.g., wavelengths of light) that penetrate
below the surface of the body, and radiation source(s) 102 are used
for treating disorders below the surface of the body. In some
embodiments, some of radiation source(s) emit forms of radiation
that penetrate to difference levels than other of the radiation
source(s) 102. In some embodiments, photodynamic therapy is
initiated with radiation source(s) 102. Photosensitizers allow for
the application of almost any wavelength. For example, a
photosensitizer can be applied to a skin lesion, and then the
radiation device can then be applied over the lesion for a long
period of time, for example by bringing the device into nearness or
contact with the skin, or by putting the device on the skin, where
the time is sufficient for a requisite dose of radiation to treat
the lesion. In the case where the device is portable, a patient
does not have to wait in a physician's office and a physician does
not have to spend valuable time manually applying a tedious
treatment. Photodynamic therapy can include a portable light source
(e.g. device 100) and a photosensitizer which can be administered
systemically or injected into a lesion or placed in close proximity
to the lesion (e.g. a cream). For example, the photosensitizer can
be applied and then the radiation applicator applied to the area
over time to activate the photosensitizer. Alternatively, the
radiation device releases photosensitizer from a reservoir or from
the substance of the device itself. For example, levulin is a
photosensitizer used in combination with yellow light for
photorejuvenation therapy.
[0072] In one embodiment, all radiation source(s) 102 produce the
same peak wavelength and/or spectrum of radiation when activated.
In another embodiment, different ones of radiation source(s) 102
produce different spectrums of radiation and/or have different peak
wavelengths. In an embodiment, whether or not all radiation
source(s) 102 are the same or some are different from others, the
spectrum of radiation produced may be controllable (e.g., by
adjusting the current) so that the wavelength or combination of
wavelengths of light may be adjusted according to the type of
disorder being treated. In some embodiments where an optical
disperser is used, a multiplicity of radiation source(s) can be
combined into a predetermined spectral output. In these
embodiments, the spectrum can be tailored by turning one or more of
the radiation sources on or off at different times.
[0073] Radiation source(s) 102 may require a power source.
Embodiments including a power source are discussed, for example, in
conjunction with FIGS. 3, 5C, and 6A, for example. Power sources
may be portable (e.g. wearable or incorporated into the device,
etc.) or non-portable (e.g. table top, wall-plug, or other wise
connected to the device via cord, etc.) Alternatively, some
radiation source(s) 102 may not require a power source. For
example, radiation source(s) 102 may produce light via fluorescence
or chemical luminescence. In another embodiment, radiation
source(s) 102 can be powered by photovoltaic cells. Alternatively,
radiation source(s) 102 may include a radioactive material that
emits alpha, beta, and/or gamma particles. For example, radiation
source(s) 102 may be discs of P-32, In-111, radioactive isotopes,
Cesium 137 and/or another radioactive material, which may be useful
for treating certain types of cancer. Additional radiation sources
can include microwave emitters, electromagnetic emitters, and
radiofrequency emitters.
[0074] Substrate 104 may take many forms. Substrate 104 may be any
suitable material such as a piece of material, which in turn may be
a strip of fabric. Substrate 104 may be solid, a mesh, or netting,
for example. Substrate 104 may be a flexible material that can be
wrapped around a limb or placed on another body part. In one
embodiment, substrate 104 is a bandage. For example, substrate 104
may have an adhesive layer on at least a portion of one surface of
the substrate such as the surface that contacts the target body
surface. Alternatively, substrate 104 does not have an adhesive
layer. In another embodiment, substrate 104 may be an article of
clothing, such as a sock, a glove, a sweater, a ski mask, a
headband, an arm band, a leg band, etc. In some embodiments, the
substrate 104 is patient compatible. If substrate 104 is not
patient compatible, then the substrate can be furthered covered
with a patient compatible material. As will be appreciated by those
skilled in the art, substrate 104 can be any material, surface or
device adapted and configured to deliver radiation therapy to a
body surface. Thus, the radiation therapy device can be configured
to delivery therapy such that the device is a therapeutic treatment
apparatus.
[0075] In another embodiment, instead of being flexible, substrate
104 is rigid and is held onto the portion of the body being treated
by being attached to a bandage or by being wrapped within a
bandage. Whether substrate 104 is rigid or flexible, a separate
substrate, such as a stocking, a glove, or a circumferential cloth,
may be utilized to hold the substrate 104 onto a target portion of
a body.
[0076] Substrate 104 may be opaque, transparent, translucent,
reflective, or made from a light scattering material. Radiation
source(s) 102 (e.g. 102a-102n) may be located on substrate 104. For
example, radiation source(s) 102 may be attached to a surface of
substrate 104 and/or formed integrally within substrate 104 (e.g.,
embedded or formed within the substrate to provide a complete,
unified radiation applicator 100). Alternatively, one portion of
the radiation source can be attached on the outside of the material
(e.g. the side of the material not facing the lesion or target body
surface) and the other side of the radiation source (e.g. the light
emitting side) is attached on the inside of the substrate (e.g. the
side of the material facing the lesion). In this embodiment, the
housing of the radiation source traverses the substrate 104 and the
power is supplied along the surface of the substrate 104 facing
away from the region of the body with the lesion. Substrate 104 may
be of a size and/or shape that facilitates securely attaching
radiation applicator 100 to a body. In an embodiment, radiation
applicator 100 can be worn by a patient without any external
attachments. In an embodiment, radiation applicator 100 may be
self-contained. Making radiation applicator 100 self-contained
and/or wearable without any external attachments (e.g., in the form
of an adhesive bandage) facilitates making radiation applicator 100
portable. A portable applicator which can be worn by a patient
under other clothes or while he or she is performing other tasks or
while sleeping may have many advantages in terms of, for example,
the quality of life of the patient and in terms of compliance.
[0077] Region 106 is a region of substrate 104 within which
radiation source(s) 102 (e.g. 102a-102n) are located. Region 106
can have a surface area that is less than the surface area of
substrate 104. Substrate region 106 may be of a size and/or shape
that is expected to cover all of, or a substantial part of, a
portion (of a body) affected by a typical occurrence of a
particular type of disorder (such as a lesion). Alternatively,
region 106 may be of a size and/or shape that is expected to be
smaller than the portion of the body affected by a typical
occurrence of a particular type of disorder. In one embodiment,
substrate region 106 is defined only by the location of radiation
source(s) 102, but is otherwise structurally identical to the rest
of substrate 104. In another embodiment, region 106 may have one or
more structural features that distinguish region 106 from the rest
of substrate 104. In one example, substrate 104 is rectangular in
shape, optionally having rounded corners, and region 106 is located
in a central portion of substrate 104 that extends nearly the
entire width of substrate 104, but only extends less than one third
or less than one quarter of the length of the substrate 104. In a
further embodiment of this example, substrate 104 is flexible and
has an adhesive in the portions 108 outside of the region 106 for
adhering to a body being treated, but no adhesive is inside of
region 106. Region 106 may be analogous in structure to the gauze
pad of a Bandaid.RTM. type bandage. In this example, region 106 and
substrate 104 are of a similar size as the gauze pad region of a
bandage for covering a cut or scrape. For example, region 106 may
include a gauze pad, and any one of, any combination of, or all of
radiation source(s) 102, controller 320 (discussed below), and/or
power source 330 (discussed below) may be located on, behind,
and/or embedded within the gauze pad.
[0078] As will be appreciated by those skilled in the art, the
controller can be adapted and configured to control the delivery of
radiation either automatically (i.e., without user intervention) or
semi-automatically (with minimal or limited user intervention). The
controller can be adapted and configured to control the amount of
radiation delivered, the time for which radiation is delivered and
the type of radiation delivered. Further, the controller can be
adapted and configured to provide a therapeutic regimen, e.g. by
altering or changing the type and/or amount of radiation delivered.
The controller, or suitable electronic circuitry, can also be
adapted to dynamically control the operation of the light sources
and to further control the therapeutic regimen delivered in
response to feedback, as will be appreciated based on the teachings
herein.
[0079] Substrate region 106 may include a protective layer for
radiation source(s) 102 that is not present in the remainder of
substrate 104. Within region 106, substrate 104 may have additional
elements or features, such as structural features, that promote
cooling, or condition the spectral output of radiation source(s)
102; for examples substrate 104 can contain a deposited reflective
layer such as aluminum in the case of UV light. Alternatively,
substrate 104 contains surface features which increase the surface
area to promote heat transfer. Other elements and features include,
but are not limited to, selectively providing perforations (not
shown) that penetrate all or a portion of the radiation applicator
100 on at least a portion of the applicator. In yet another
embodiment, region 106 may be a piece of removable material that
supports radiation source(s) 102. Having a removable substrate
region 106 allows the same substrate 104 to be used with a
multiplicity of different sets of radiation source(s) 102 in which
each set is designed for treating a different disorder or set of
disorders. In another embodiment, a material covers region 106.
This material is a disposable material which is transparent to the
radiation from radiation source(s) 102 and is discarded after the
therapy, allowing the devices in region 106 to be reusable without
concern for the devices being soiled. In another embodiment,
substrate region 106 may be absent, and radiation source(s) 102 may
be uniformly distributed throughout substrate 104.
[0080] FIG. 2A shows an example of a portion of a body 10, e.g. a
target portion of a human body, such as a skin layer, while being
treated. During treatment of body portion 10, radiation applicator
200 is placed on a lesion 20 on body portion 10. Lesion 20 can be
any patch of unhealthy or unwanted tissue surface that is expected
to be at least partially treatable by irradiating with radiation,
such as light. (Lesion 20 is illustrated with a dashed line in FIG.
2A because lesion 20 is under radiation applicator 200 and
specifically under region 206.) Body portion 20 is any target
external surface of a body, e.g., skin. For example, portion 20 may
be a portion of skin on a limb (e.g., the arm), or the hand of a
patient. In the embodiment of FIG. 2A, substrate 204 is a single
opaque layer and radiation source(s) 202 (e.g. 202a-202n) are
placed on one side of substrate 204. Consequently, radiation
source(s) 202 (e.g. 202a-202n) are drawn with dashed lines to
indicate that radiation source(s) 202 are between substrate 204 and
lesion 20, so as to irradiate lesion 20 without being impeded by
substrate 204. Similar to FIG. 1, the various dashed lines between
radiation source(s) 202 indicate that there may be any number of
radiation source(s) in that location spanning the region of the
dashed lines and between the dashed lines. Although FIG. 2A
illustrates an embodiment in which substrate 204 is a single opaque
strip, any of the other embodiments of radiation applicator 200 may
be used instead.
[0081] If substrate 204 is transparent or translucent to the
radiation source(s) 202, then substrate 204 could be placed between
radiation source(s) 202 and lesion 20. An advantage to placing
substrate 204 between radiation source(s) 202 and lesion 20 is that
radiation source(s) 202 may be left exposed to air, which may
facilitate passive and/or active (e.g. a thermoelectric cooling
device) cooling of radiation source(s) 202. Additional structural
elements such as fins or other heat diffusing, heat dispersing,
and/or heat sinking elements can be attached or manufactured on
substrate 204; additionally, electrodes or other conductive paths
can be applied to or manufactured on substrate 204. Processes such
as chemical or vapor deposition processes can be used to deposit
heat conducting or electrically conducting materials on substrate
204. Alternatively, the radiation source(s) 202 may be adapted to
traverse the material so that the light emitting face is placed
between the substrate 204 and lesion 20 and the electrical
connections and heat generating components are such that they
direct heat away from the lesion 20 (and/or electricity toward the
radiation source(s) 202) through the substrate 204, and then to the
ambient atmosphere. Also, substrate 204 may include elements and/or
structural features that facilitate uniform irradiation of lesion
20, such as by scattering or focusing the radiation emitted from
radiation source(s) 202. One example of a scattering structure is a
substrate having one or both of its outer surface and its surface
facing radiation source(s) 202 roughened or textured. Another
example of a scattering structure is a substrate having particles
(e.g. titanium oxide and/or aluminum oxide) embedded within it that
have a different index of refraction than the substrate. Any one
of, any combination of, or all of these scattering structures may
be included in substrate 204 (and/or within other layers) for
uniformly irradiating lesion 20.
[0082] An advantage in placing radiation source(s) 202 between
substrate 204 and lesion 20 is that a greater percentage of the
radiation generated is incident upon lesion 20. Consequently, the
power efficiency may be greater without substrate 204 intervening
between radiation source(s) 202 and lesion 20 than with substrate
204 in an intervening position.
[0083] FIG. 2B illustrates a target body surface, such as a layer
of skin 70. The layer of skin is comprised of the stratum corneum
50, the stratum lucidum 52, the stratum granulosum 54, the
germitive layer 56, 58 and the dermis 60. Lesion 20 is depicted
crossing all of the layers for purposes of illustration. However,
as will be appreciated by those skilled in the art, the layers of
the skin affected by the lesion will be determined by the type and
extent of medical condition associated with the skin, e.g.
psoriasis, contact dermatitis, vitiligo, acne, atopic dermatitis,
cellulite, collagen laxity associated with aging, and skin cancer.
In this illustration, the radiation applicator 200 is positioned on
the target body surface to be treated such that the radiation
source(s) 202 will be in proximity to the lesion 20. As described
above and below, the radiation applicator can contain a multitude
of radiation generators which alone or in combination can apply
radiation to difference depths within the lesion. For example,
infrared wavelengths can be used to penetrate the deeper parts of
the lesion whereas ultraviolet wavelengths can be used to penetrate
the more superficial portions of the lesion. Photosensitizers can
further be utilized to modulate the depth of penetration. For
example, if a red light absorbing photosensitizer is applied
superficially to the lesion, then the superficial portion of the
lesion is treated with the red light. In this embodiment, the depth
wherein light activates the photosensitizer is determined by the
depth where the photosensitizer is placed or level it is absorbed
to. If the photosensitizer is injected 2 mm underneath the skin,
then the light will be absorbed in this layer assuming that light
is not absorbed in the more superficial layers of the skin.
[0084] FIG. 3 shows a block diagram of an example of radiation
applicator 300. Similar to FIG. 1, FIG. 3 shows radiation source(s)
302 (e.g. 302a-302n), substrate 304, and region 306. Additionally,
FIG. 3 shows controller 320, power source 330, and electrical
connectors 322. In other embodiments, radiation applicator 300 may
not have all of the components associated with FIG. 3 and/or may
have other components in addition to, or instead of, those depicted
for purposes of illustration with FIG. 3. Radiation source(s) 302,
substrate 304, and region 306 were described in conjunction with
FIGS. 1 and 2A-B. Controller 320 may function as an on/off switch.
Controller 320 may include a processor and/or a specialized circuit
for controlling radiation source(s) 302. Controller 320 may be a
microcontroller. For example, controller 320 may have a width
and/or length that are less than 5 cm, less than 4 cm, less than 3
cm, less than 2 cm, or less than 1 cm. As discussed above,
controller 320 can be adapted and configured to control radiation
source(s) 302 and may control how long and/or which ones of
radiation source(s) 302 is/are powered on. Additionally, or
alternatively, controller 320 may control the wavelength,
frequency, and/or the intensity of the radiation of radiation
source(s) 302. In addition, controller 320 can integrate feedback
from reflectance sensors (not shown) associated with the device 300
which relay real-time information about the state of the lesion or
of the surrounding skin. Controller 320 further has the ability to
be programmed from a device (e.g. a wireless or wired device such
as a computer, personal digital assistant, etc.) outside the
radiation applicator 300. A therapeutic treatment may be provided
where the specific areas of a patient's body surface considered to
be affected (for example, containing a plaque or lesion)
substantially receive a majority of the dose provided by the
delivery device. In an embodiment, there is at least one sensor
located on the device that can provide feedback to an operational
controller 302. This sensor (not shown) has the ability to detect
the physical condition of a particular area of a patient's body
surface. This physical condition can be evaluated by assessing one
or more of the following characteristics: photoreflectance,
temperature, electrical impedance, hardness, thickness, moisture,
or acoustic reflections, among others. Photoreflectance may measure
roughness, color, fluorescence, or other characteristics. The
controller can process the information and determine whether or not
the particular body surface may receive radiation. As an example,
based on input from the previously described sensor, controller 302
can determine whether or not a particular segmented region of a
body surface contains an affected area or not. In practice, the
device described herein may be placed on a body surface containing
areas that are in need of treatment along with areas that are
considered healthy and otherwise not requiring therapy. Therefore
it would be entirely beneficial to enable sensing of the specific
location of, for example, a psoriasis plaque residing on a body
surface within the periphery of device 100. Subsequent to this
detection step, a therapy can selectively be applied only to the
plaque region. This can be accomplished by selectively enabling the
one or more radiation source(s) 102 with respect to a particular
area on such a body surface.
[0085] In an embodiment, controller 320 may relieve the patient
and/or doctor from the task of keeping track of the time that the
therapy has been applied. For example, controller 320 may track the
total amount of time that each individual one of radiation
source(s) 302 and/or each of a plurality of groups of radiations
source(s) 302 has been in use. In other words, each of radiation
source(s) 302 may be turned on and off in cycles, and controller
320 or a timer (not shown) may keep track of the total amount of
time and/or total energy that any given radiation source(s) has
been kept on. The controller in some embodiments facilitates the
portability of the device. If the dosage being applied to the
patient is not being monitored by the physician or the patient it
would therefore be possible that too high a dose is delivered to
the treatment area. With a controller 320 various groups of
radiation source(s) 302 may be turned on and off together,
separately or not at all while keeping track of how long an
individual radiation source has been on and/or how long a group of
radiation source(s) associated with this individual radiation
source has been on, (because the group of radiation source(s) and
any individual radiation source within the group is expected to
have been on for the same amount of time). In some embodiments, the
device is provided with a computer interface so that the patient or
doctor programs the computer interface and subsequently the device
to achieve a specific dose on one or more target areas. For
example, the user of the computer interface determines the region
to be treated and the dosage to be applied. This methodology
ensures that a specific dosage is applied to a specific (e.g.
diseased) location on the body surface. In this way, the ideal
toxicity: efficacy ratio can be obtained.
[0086] When a particular one of, or group of, radiation source(s)
302, has delivered a predetermined therapeutic dose of energy,
radiation controller 320 turns off or otherwise decreases its
applied dose 302. A therapeutic dose of radiation may be an amount
of radiation that has been determined to be the maximum or slightly
less than the maximum tolerable dose during a particular treatment
session. Tolerable can mean a sunburn in the case of ultraviolet
light applied to the skin. Alternatively, a therapeutic dose of
radiation may be an amount of radiation that has been determined to
be appropriate for a particular disorder or a particular treatment
session. As will be appreciated by those skilled in the art,
different disorders may have different therapeutic doses. For
example, a therapeutic dose may be a sub-threshold Minimal
Erythemal Dose ("MED") in some skin disorders. As another example,
a therapeutic dose may be reached when all the radiation source(s)
302 or when all of the groups of radiation source(s) 302 have
delivered 100-600 mJ/cm.sup.2 (of ultraviolet light in the 295-320
nm range for example) to body portion. Consequently, when all of
the groups of radiation source(s) 302 have delivered 100-600
mJ/cm.sup.2 to portion, the therapy for that region is
finished.
[0087] Although FIG. 3 shows an example in which there is only one
controller 320, there may be a plurality of controllers. Each one
of radiation of sources 302 or each group of radiation source(s)
302 may have its own controller. There may be a system of
controllers in which there is one master controller that controls
other local controllers, and the local controllers may control
individual ones of and/or groups of radiation source(s) 302.
Optionally, controller 320 may have one or more input ports or
input devices that may be used for programming, inputting
parameters, and/or setting controller 320 according to a particular
therapy, which may be based on a calibration that was performed.
The programming, input parameters, and/or settings may be entered
by a patient, entered by a doctor, and/or automatically entered as
part of a calibration and/or setup procedure. Examples of inputs
include, but are not limited to, Bluetooth.RTM., USB, optical, or
any other wired or wireless connections.
[0088] Power source 330 powers controller 320 and/or radiation
source(s) 302 are provided for as shown in FIG. 3. In the example
of FIG. 3, power source 330 supplies power to radiation source(s)
302 via controller 320. Power source 330 may be one or more
batteries, a power supply that plugs into an outlet, and/or one or
more photocells for recharging one or more batteries. Power source
330 may include one or more flat, disc-shaped batteries, which may
be less than 2 or 3 millimeters thick, and less than 1 or 2
centimeters in diameter. For example, power source 330 may be one
or more lithium ion batteries. Alternatively, power source 330 may
be one or more nickel cadmium, AA, and/or AAA batteries, for
example. Although in the example of FIG. 3 there is only one power
source shown, there may be a plurality of power sources located in
a plurality of locations within radiation applicator 100. Each one
of, or each group of, radiation source(s) 302 (e.g. 302a-302n) may
have their own power source. Power source 330 may be located on
substrate 304. In an embodiment, power source 330 is an integral
part of substrate 304 (e.g., power source 330 may be embedded
within substrate 304). In another embodiment, power source 330 is
one or more photovoltaic cells.
[0089] Depending upon the configuration of the radiation applicator
300, the weight of the device can range from, for example, 0.5 g to
200 g, more preferably from 0.5 g to 100 g, and even more
preferably from 0.5 g to 10 g. As will be appreciated by those
skilled in the art, these weight ranges are meant to be
illustrative of a reasonable weight which an individual can
tolerate. Other weight ranges could be used without departing from
the scope of the invention.
[0090] Electrical connections 322 communicatively connect radiation
source(s) 302 (e.g. 302a-302n) to controller 320 so that controller
320 is capable of controlling radiation source(s) 302. Electrical
connections 322 also electrically connect power source 330 to
radiation source(s) 302, via controller 320, such that power source
330 supplies power to radiation source(s) 302. Electrical
connections 322 may include a bus that sends signals to individual
radiation source(s) 302. Alternatively, electrical connections 322
may include individual pairs of electrical connections, where each
pair links one of, or one group of, radiation source(s) 302
directly to controller 320.
[0091] Electrical connections 322 may be attached to substrate 304
individually or they may be created directly on the material by a
process of photolithography, electrodeposition, chemical vapor
deposition, and/or physical vapor deposition. Alternatively,
electrical connections 322 are embedded in a flexible insulating
film, the entire film then being attached to substrate 304.
Electrical connections 322 can be wire-bonded connections produced
using a wire bonding process well-known in the LED arts. These
connections are three dimensional and can be protected via material
film around the connections. One representative example of a
flexible film is a silicone film. A silicone film can be used to
embed wires which lead to a connector such as a computer pin
connector. After the bus and the wires are embedded, the film can
be mated with another film which is a radiative device or a heat
conducting film. When the two sides (film with the wires and film
with the LEDs) are mated to one another, the device is electrically
connected.
[0092] A method of applying radiation therapy in the context of
this invention includes the steps of: visualizing a body surface to
be treated; mapping the body surface to be treated in a device
interface; delineating an area of the body surface to apply
radiation therapy to; programming a topologic dosage map to the
radiation therapy device via the computer interface; applying the
radiation therapy device to the body surface in an orientation
where the topologic dosage map align with the underlying disease
being treated; and allowing the radiation therapy device to
function autonomously after the device applied to the body
surface.
[0093] In some embodiments, doses are applied to the treatment
region on a continuous basis and the maximum therapeutic dose
guides the therapy. For example, a time can be defined, over which
a maximal dose cannot be exceeded. Using the skin as an example, an
MED, a fraction of an MED, or a multiple of an MED can be given to
a body region over a 30 second period, a 12 hour period, a 24 hour
period, a 48 hour period, or over any period of time in between or
other time chosen by the patient or the physician; it is also
conceivable that erythema (in the skin for example) can be avoided
altogether when the dose is given over a long period of time. After
this period of time, another dose is give to the same region or
another region. In other embodiments, the dose delivered to the
region with the lesion can exceed the toxicity dose of the
non-lesional region because the radiation device can selectively
apply radiation to one region versus another region and the
application region can be programmed into the device by the
physician or the patient. For example, in the case of psoriasis,
the dose that can be delivered to the region with a psoriatic
plaque can exceed the minimal erythemal dose by a factor of, for
example, 2,3,4,5,6,7,8,9, or 10 because the psoriatic region is
more resistant to radiation than normal skin. With most existing
devices, it is not possible to define a treatment region while
avoiding non-treatment regions. It is typically the responsibility
of the operator of the device to apply radiation to unhealthy
regions and not healthy regions.
[0094] In an embodiment of the method, a radiation applicator, such
as applicator 100, may be programmed by the patient or by the
physician to deliver a particular therapy over a period of time. In
an embodiment, controller, such as controller 320, may be
programmed to calibrate radiation applicator or have a calibration
mode during which radiation applicator is calibrated. For example,
radiation applicator may be calibrated for the patient prior to
applying a therapy (e.g. due to the fact that different patients
have different sensitivities to light due to differing amounts of
melanin contained in a patient's skin).
[0095] During calibration, radiation applicator is placed on a
portion of the body that is unaffected by the disorder that portion
is affected by. For example, radiation applicator is placed on a
portion of healthy skin typically unexposed to sunlight (e.g., the
gluteal region). Next, escalating doses of radiation are applied to
the skin. The dose, which after 24 hours produces a superficial
redness of the skin from dilation of the capillaries, or erythema,
is called the Minimal Erythemal Dose (MED). Controller may be
programmed to automatically apply the escalating doses to different
regions under radiation applicator. After 24 hours, the MED is
determined by the region which has a perceptible erythema, or
redness. The patient's MED is then programmed into controller and
the MED, or an amount of radiation slightly less than the MED,
becomes the calibrating dose for the particular patient. This
device configuration can also be utilized to diagnose disease. For
example, the disease state, polymorphic light eruption, is a
disease in which an allergic response occurs with light exposure.
It is typically a tedious process to diagnose the specific
wavelengths and/or power required for the allergic response to
light, requiring a large amount of technician time and equipment. A
radiation device 100 can be used for diagnosis in some embodiments.
For example, radiation device can have a multitude of radiation
sources with different wavelengths, each of which deliver specific
energies in different wavelength bands. The radiation device can
then be applied to a body surface (e.g. skin) with a program to
deliver a specific wavelength and/or dose to different body surface
areas under the device over specific times. After the doses are
delivered, the region which develops the skin reaction can be
determined by observing the region which has the reaction.
Similarly, a radiation device can be used to determine body
reactions to photosensitizing pharmaceuticals, cosmetics,
natriceuticals, and sunblocks. In the case of sunblocking
compounds, various compounds can be placed underneath the radiation
device and prescribed doses of radiation programmed into the
device. The radiation applicator in these diagnostic embodiments
can further be adapted to fit animals, such as pigs, rats or mice
which are often used to test the potential photosensitizing
compounds.
[0096] To treat a disease such as psoriasis, doses are typically
related to the MED. For example, a standard course of therapy
consists of 3 weeks of treatments, 3 times per week, with each
treatment consisting of 1-3 MED depending on what the patient can
tolerate. It is difficult, if not impossible, for the treatment
area to be well-controlled; some areas of non-diseased skin will
receive treatment. It is these areas which limit the amount of
radiation which the affected areas can receive. Further, the risk
of skin cancer is increased in the areas unaffected by disease but
which are nonetheless exposed to radiation because of the
non-specificity of the radiation applicator. Furthermore, the
treatments are given three times per week solely because the
unaffected skin must heal before the next treatment. A device which
could limit treatment area to the lesional area could be beneficial
in that the treatment dose and/or frequency could be increased and
the total treatment time decreased. Furthermore, a device which
does not require the patient to be at the physician's office or
otherwise schedule time for a treatment could be highly beneficial
in many patients and result in greater treatment protocol
compliance by the patient which in turn would lead to greater
efficacy of patient treatment. With radiation applicator, the
treatment region can be finely tuned by the patient and/or
physician. In embodiments where the device is worn by the patient,
the patients do not have to stop what they are doing (e.g. work,
sleep, exercise, etc.) to receive treatments.
[0097] In embodiments in which controller is kept small (e.g., in
embodiments in which controller is a microcontroller), the small
size facilitates making radiation applicator portable. Controller
may be located on substrate. In an embodiment, controller is an
integral part of substrate (e.g., controller may be embedded within
substrate). Controller switches power between different radiation
source(s), so that some of radiation source(s) are powered on while
others are powered off. In an embodiment, controller may never, or
only infrequently, power on all of radiations sources
simultaneously. Alternatively, controller will have at least some
period of time when not all of radiation source(s) are powered on
simultaneously. If controller does not keep at least some of
radiation source(s) (although not necessarily the same radiation
source(s)) off all of the time, nearly all of the time, most of the
time, or at least some of the time, the current required for
operation may be very high and may generate excess heat in addition
to requiring a very large power source as compared to the operating
current required, the heat generated, and the size of the power
source when some or all radiation source(s) are turned on and off
to conserve power. A large power source and excessive heat
dissipation requirements may require component sizes that limit the
portability of a radiation applicator and the ease and/or comfort
with which radiation applicator can be worn. The selective
activation of radiation source(s) and the duration of radiation
source activation time (e.g., the duty cycle) may be based upon the
power capacity of a power source, which is kept small enough to
keep radiation applicator portable and self-contained.
Alternatively, or in addition to, the amount of time that a given
one of radiation source(s) is kept on may be based upon cooling
considerations and/or a desired intensity of radiation that is
expected to be therapeutic. In an alternative embodiment, radiation
applicator is connected to an external computer or an external
controller during, before, or after operation or is at least in
part controlled wirelessly by a remote unit during, before, or
after treatment. Additionally, as will be appreciated, the power
source may be contained in a water-resistant or water-proof housing
(not shown). The housing may be configured to be connectable to the
radiation applicator in such a manner that the connectors between
the radiation applicator and the housing can be connected in a
manner that provides a secure moisture resistant connection.
[0098] Using a microcontroller for controller may simplify the
structure of the radiation applicator as well. For example, in an
embodiment in which each of radiation source(s) (e.g. 102a) is on
for only a short period of time before being turned off and another
one of radiations sources being turned on, heat transfer through
substrate is not as large an issue as it would be if all of
radiation source(s) were run continuously. Consequently, there may
not be any need to pump a fluid through radiation applicator for
cooling. Similarly, there may not be any need for perforating
substrate for cooling.
[0099] Optionally, radiation applicator may include one or more
detectors to detect whether the body surface of the patient has
been harmed and/or may be harmed soon. For example, radiation
applicator may include one or more detectors to detect erythema.
The detectors may detect erythema by detecting the color of a
target portion of the body or a change in the color of a target
portion of the body (e.g., skin color). In another embodiment,
there may be detectors for detecting the color, moisture, and/or
temperature of the target portion being irradiated to ensure that
the portion irradiated is not being damaged by the radiation.
Optionally, after detecting erythema and/or any other condition
indicative that radiation applicator may have harmed, or may harm,
the target portion being irradiated, controller may automatically
turn off radiation source(s). Controller may turn off the radiation
source(s) associated with the erythemal region as part of the
calibration routine and/or as a safety feature during a treatment
in response to input from one or more detectors concerning the
condition of the region being irradiated (e.g., after an erythemal
condition is detected).
[0100] FIG. 4 shows a block diagram of an example of controller
420. Controller 420 may include processor 402, memory 404, and
signal generator 415. Memory 404 may have a therapy program 406,
calibration program 408, and/or other programs 410. Memory 404 may
store MED 412 and/or other parameters such as the dose history
previously applied to the patient. Controller 420 may also include
one or more input ports 414 and one or more output ports 416. In
other embodiments, controller 420 may not have all of the
components associated with FIG. 4 and/or may have other components
in addition to or instead of those associated with FIG. 4.
[0101] Processor 402 performs the therapy program and/or
calibration programs referred to above and/or other programs.
Memory 404 may include one or more machine-readable mediums that
may store a variety of different types of information.
[0102] The term machine-readable medium is used to refer to any
medium capable of carrying information that is readable by a
machine, such as processor 402. One example of a machine-readable
medium is a computer-readable medium. Although machine-readable
medium of memory 404 is capable of storing information for a period
of time that is longer than the time required for transferring
information through memory 404, the term machine-readable medium
may also include mediums that carry information while the
information that is in transit from one location to another, such
as copper wire and/or optical fiber.
[0103] Memory 404 stores programs that are executed by processor
402 and/or parameters used by those programs. In this
specification, the word program is used to refer to any group of
one or more instructions that cause a processor to perform at least
part of a task when the one or more instructions are executed. In
the example of FIG. 4, memory 404 may store therapy program 406
and/or calibration program 408 and or dose history program. Therapy
program 406 and calibration program 408 include one or more
instructions that cause processor 402 to perform the therapy and
the calibration discussed in conjunction with FIGS. 1-3,
respectively. Memory 404 may also store other programs 410, which
are optional. If present, other programs 410 may include one or
more other programs entered by the doctor or patient.
[0104] MED 412 (such as discussed in conjunction with FIG. 3)
and/or other parameters may be entered by a patient or doctor
and/or may be determined and/or stored automatically. One or more
input ports 414 may be connected to one or more input devices for
entering programs and/or parameters into memory 404. One or more
input ports 414 may also receive input from one or more detectors
used for calibrating radiation applicator, e.g. device 100. One or
more input ports 414 may be useable as an interface to a computer
or other machine that is used for programming controller 420. One
or more input ports 414 may be useable for downloading programs, an
MED, configuration parameters, and/or other information to
controller 420. Input ports 414 may include an input port for a
wireless signal (e.g., an antenna). Alternatively, a computer or
other machine may be attached to one or more input ports 414, and
used to either directly control radiation sources or control
radiation source(s) via controller 420.
[0105] Signal generator 415 may produce a variety of different
signals that vary in pulse width, pulse height, and/or pulse shape.
Signal generator 415 may produce signals having different duty
cycles based on the capabilities of power source 430, and based on
how much heat is generated by radiation source(s) (e.g. radiation
sources 102a-102n) while in an on state and/or a desired therapy.
Signal generator 415 may be controlled by processor 402. Signal
generator 415 is optional. In an embodiment in which signal
generator 415 is not present, processor 402 may address radiation
source(s) directly.
[0106] One or more output ports 416 may be associated with the
controller 420 and may be connected, via electrical connections, to
radiation source(s). There may be one output port 416 for each one
of, or each group of, radiation source(s). One or more output ports
416 may be capable of being connected to one or more output
devices, such as a monitor and/or display. By connecting an output
device, it may be possible to view programs and/or parameters
entered into memory 404 to aid in programming processor 402 and/or
debugging one of the programs stored on memory 404. If signal
generator 415 is present, some of the one or more output ports 416
may be connected to corresponding outputs of signal generator 415,
and some of the one or more output ports 406 may be connected
directly to processor 402 for communicating with an external
device, such as a computer or terminal.
[0107] FIG. 5A shows a schematic diagram of an example of radiation
source 500. Radiation source 500 may include the actual radiation
source 502, such as a light source, and its supporting elements
which allow the radiation source to function. For example, if the
radiation source is a light emitting diode (LED), the supporting
elements can include mount 514, header 516, lead 518, and lead 510;
these supporting elements can be referred to as the radiation
source module. In other embodiments, radiation source (or radiation
source module) 500 may not have all of the components associated
with FIG. 5A and/or may have other components in addition to, or
instead of, those associated with FIG. 5A. Furthermore, as would be
recognized by those skilled in the art, many variations of these
basic components are possible. For example, the mount 514 could be
made from any of many shapes, sizes, thicknesses, or from materials
such as Beryllium Oxide (BeO), Aluminum Nitride (AlN), alumina,
aluminum, copper, steel, MgF.sub.2, or a semiconductor (e.g.
silicon). The leads 518, 510 can be made from copper, silver, gold,
alloys, or polymers as would be recognized by those skilled in the
art. Header 516 can be made from a variety of materials or made
into many shapes. Header 516 can also contain features necessary
for heat transfer such as fins or dimples to increase the surface
area of the header. The header can also be manufactured by
depositing or molding metal (e.g. Kovar.RTM., an alloy of iron,
nickel and/or cobalt which has similar thermal expansion properties
to glass, Westinghouse Electric & Manufacturing, Pittsburgh
Pa.) directly onto a flexible material (e.g. silicone), which is
part of the applicator 104 in FIG. 1. The radiation source can then
be placed, using a die bonder, onto the deposited Kovar, after
which wire bonds or soldered welds can be used to attach the
radiation sources to a power circuit. Alternatively, the wire bonds
can also be deposited on the flexible substrate (e.g. surface 104
in FIG. 1) using deposition processes such as electrodeposition,
chemical vapor deposition, or physical vapor deposition.
[0108] Radiation source 502 may be a surface mount LED, or LED die,
such as a UV LED die, blue light LED die, white light surface mount
(SMD), Infrared (IR) LED or SMD, or UV LED SMD. As another example,
radiation source 502 may be a small light bulb, resistive heater,
or a device for generating microwaves, radiofrequency energy,
X-rays, and/or radio frequency light. More specifically, radiation
source 502 can emit energy in the immunosuppressive or
anti-infective range of the ultraviolet spectrum. Wavelengths
included in the immunosuppressive range of the ultraviolet spectrum
include those from 295 nm to 320 nm and/or from 340 nm to 400 nm.
In other embodiments where it is desired to treat infectious
agents, radiation source 502 can emit ultraviolet light in the
range 250-300 nm.
[0109] In an embodiment where radiation source 502 is a light
source, mount 514 may hold light source 502 in place. Mount 514 may
include a heat sink, circuit board, or a circuit board on top of a
heat sink (e.g., a passive heat sink to diffuse heat over a larger
surface area or an active sink to electrically pump heat away from
the light generating regions). One example of a circuit board
(sub-mount) is a gold-patterned ceramic such as beryllium-oxide
(BeO) or aluminum nitride (AlN); the ceramic can act as a heat sink
or a highly conducting heat transfer element through which heat
conducts to the heat sink. Mount 514 may be a material such as
Kovar alloy, which can act as a heat sink in addition to the
ceramic material and is a very good material to bond beryllium
oxide or aluminum nitride to because it (Kovar alloy) has a very
similar coefficient of heat expansion. If mount 514 includes a heat
sink, mount 514 may reduce the likelihood of light source 502
overheating and/or may otherwise extend the lifetime of light
source 502 so that light source 502 lasts longer with a higher
optical output per electrical input (efficiency) than if there were
there no heat sink. Although in the example of FIG. 5, there is
only one light source 502 on mount 514, there may be plurality of
light sources on each mount 514. Light source 502 (e.g., an
individual or multitude of UV LEDs) may be attached (e.g., bonded)
to mount 514 using a eutectic metal or a solder such as gold-tin,
lead-tin, other applicable eutectic solder material. Optionally,
mount 514 may be textured (e.g., roughened) for scattering light or
polished for specularly reflecting light. Mount 514 may be shaped
for concentrating, diffusing, collimating, or dispersing light from
light sources 502. Mount 514 may be flat, concave, or convex. If
mount 514 is concave or convex, mount 514 may be elliptical,
spherical, or hyperbolic, for example. Mount 514 may be composed
of, or coated with, a reflecting metal such as aluminum or aluminum
derivative. Mount 514 can additionally contain three-dimensional
features 530 which are deposited on mount 514 (FIG. 5E).
[0110] Further, with respect to FIG. 5E a radiation source is
depicted in the center of two three-dimensional pillars 534. The
pillars can be deposited onto mount 505 or they can be attached
after being made by another mechanism. Typical attachment processes
can include a press fit, eutectic mount, adhesive mounting,
ultrasonic welding, and light based curing. Mounting elements 530
can be electrical mounts, a material solely intended for the
mounting process, a material to facilitate heat transfer, or a
combination thereof The radiation source (e.g. a light source) can
be placed in between the three-dimensional pillars 534 so that the
radiation will reflect or refract forward from the
three-dimensional pillars 534 in a pre-determined pattern outward
to the body surface. As will be appreciate by those of skill in the
art, the three-dimensional pillars 534 can assume any of a variety
of configurations other than the pillars depicted without departing
from the scope of the invention.
[0111] An advantage of placing pillars 534 around the radiation
source or multiple individual radiation sources is that the
radiation from the individual radiation sources can be captured
independently from other radiation sources nearby. Such an
arrangement can optimize light extraction and can direct the
radiation in specific directions. Three-dimensional pillars 534 can
be deposited on the surface 505 of the mount using processes such
as eletrodeposition, chemical vapor deposition, physical vapor
deposition, micromolding, electroforming, or other deposition
processes known to those skilled in the art. In one example, mount
514 is made from a ceramic such as Beryllium Oxide or Aluminum
Nitride. Standard physical vapor deposition processes can be used
to then deposit conducting metallic layers such as gold or a
eutectic metal such as gold-tin on the ceramic. With a conducting
surface such as gold deposited on the ceramic, additional features
can then be deposited (e.g. with an electrodeposition process) on
the conducting metal which would reflect, focus, concentrate,
disperse, or otherwise condition light. In another example, three
dimensional features are not deposited directly but are produced in
separate molds which are then applied to the surface 505 of the
mount 514. When the surface pattern in the mount 514 is made from a
eutectic metal, the mold placed on the mount surface and heat is
then applied to the mount 514. The heat can weld the eutectic metal
to the three-dimensional piece in the mold; after cooling, the mold
is removed, leaving the mount 514 with a three-dimensional feature
530 welded to it. A combination of these processes can also be used
in which three-dimensional features 534 are fabricated and then
additional layers 532 are deposited on top of the three-dimensional
features. For example, UV reflecting aluminum could be deposited on
top of the three-dimensional features 534 on the mount 514. Light
is then directed from radiation source 502 using one or all of
these processes and/or structures.
[0112] Header 516 may protect light source 502 and mount 514 from
being separated. Although in the example of FIG. 5A-E, header 516
has only one mount 514, there may be plurality of mounts 514 and
each mount may have only one light source or may have a plurality
of light sources. Similar to mount 514, header 516 may be shaped
for concentrating, diffusing, collimating, dispersing, or otherwise
reflecting light (e.g., with an aluminum reflecting layer) light
from light sources 502. Header 516 may be flat, concave, or convex.
If header 516 is concave or convex, header 516 may be elliptical,
spherical, or hyperbolic, for example. Alternatively, there may be
another optical component in addition to, or instead of, shaping
and/or texturing mount 514 and/or packaging header 516 to have
particular optical properties. Specifically, this additional
optical component may be shaped for concentrating, diffusing,
collimating, or dispersing light from light sources 502. The
additional optical component may be flat, concave (for dispersing
the radiation), or convex for concentrating the radiation. If the
additional optical component is concave or convex, the additional
optical component may be elliptical, spherical, or hyperbolic, for
example. Header 516 can also contain three-dimensional
microfabricated components as described above in the mount. The
same or similar processes can be employed for the header.
[0113] In an embodiment, mount 514 and header 516 are separate
components that are attached to one another. In another embodiment,
mount 514 and header 516 may be two parts of the same component
and/or only one of mount 514 and header 516 are used. If there is
more than one light source on each mount 514 and/or within each
header 516, the light sources may all have the same spectrum and/or
may be associated with the same peak wavelength. Alternatively,
there may be different light sources having different spectrums
and/or peak wavelengths that are located on the same mount 514
and/or one the same header 516.
[0114] The leads 518, 510 supply power to light source 502 for
activating light source 502 and keeping light source 502 lit.
Further, leads 518, 510 may be connected to larger leads on
substrate 104 that bring electricity to radiation source 502 (e.g.,
leads 518 and 510 may be connected to electrical connections 322).
As will be appreciated by those skilled in the art, leads 510, 518
may be made from an alloyed, eutectic or non-alloyed, metal placed
on or bonded to mount 514. Thus, current from power source 330
flows to controller 320, through electrical connections 322, and to
one or more of radiation source(s) 102 (e.g., to leads 518 and 510,
and then to light source 502, such as an UV LED), resulting in
light, such as UV light, being output and subsequently biologic
effect.
[0115] FIG. 5B shows a cross-section of an embodiment of radiation
applicator 500. The embodiment of FIG. 5B includes flexible
substrate 104, light source 502, mount 514, header 516, spectral
conditioner 550, and optional patient interface 512. In other
embodiments, radiation applicator 100 may not have all of the
components associated with FIG. 5B and/or may have other components
in addition to, or instead of, those associated with FIG. 5B.
[0116] Substrate 104 is discussed above in conjunction with FIG. 1
and elsewhere. Light source 502, mount 514, and header 516 are
discussed above in conjunction with FIG. 5. Spectral conditioner
550 covers and may protect light source 502 from damage and/or may
condition the radiation in one or more ways before it reaches the
lesion. Spectral conditioner 550 may be one continuous layer of
material that extends over all of region 506 or over all of
substrate 504. Alternatively, spectral conditioner 550 may be a
collection of patches of material, where each patch conditions the
radiation from at least one light source, such as light source 502.
In this embodiment, when the spectral conditioner 550 is a patch
and individually covers one light source, the entire light source,
including the covering 513, header 516, and mount 514 can be
individually removed from the material 504 and then replaced on
material 504. Depending on the embodiment, spectral conditioner 550
may cover a larger area than light source 502 but smaller than or
equal to mount 514, cover a larger area than mount 514 but smaller
than or equal to header 516, or cover a larger area than header 516
but not large enough to reach a covering of an adjacent radiation
source.
[0117] Spectral conditioner 550 may make radiation applicator 500
more comfortable to wear, because the surface of spectral
conditioner 550 that contacts the body portion can be smoother than
the surface of radiation applicator 100 than if spectral
conditioner 550 were not present. Spectral conditioner 550 and
substrate 504 may form two layers of material, with light sources
502 sandwiched in between. Spectral conditioner 550 may be a layer
of material, which may be transparent or translucent (e.g. to
ultraviolet light between 250 nm and 320 nm), while a substrate 504
may be transparent, opaque, translucent, or reflective. If
substrate 504 is reflective, substrate 504 may be specularly
reflective or may scatter light. By making substrate 504
reflective, the efficiency of radiation applicator 500 is improved
as compared to where substrate 504 is not reflective. By making
either or both of substrate 504 and covering 513 a light scattering
material, the uniformity of the irradiation may be improved as
compared to if substrate 504 and/or spectral conditioner 550 do not
scatter light. Spectral conditioner 550 may be made to scatter
light using any of the structures discussed above in conjunction
with the discussion of substrate 204 of FIG. 2. Spectral
conditioner 550 may reduce efficiency (depending upon how much
radiation it absorbs or otherwise prevents for reaching the
patient), but may improve the uniformity of the irradiation and/or
comfort to the patient.
[0118] Optional patient interface 512 may be an adhesive to help
radiation applicator 500 adhere to the body portion being treated.
Optional patient interface 512 may be a layer of adhesive material
(e.g., glue) that partially or completely covers one surface of
radiation applicator 500, such as covering 513. Optional adhesive
may be included in an embodiment in which radiation applicator 500
is a bandage that sticks to a portion of skin of a patient, for
example. Optional adhesive may the adhesive discussed in
conjunction with FIG. 1 and/or substrate 504. In addition to glue,
patient interface 512 may incorporate therapeutic substances
designed to prevent damage and/or enhance the therapeutic efficacy
of the radiation delivered by radiation applicator 500. Examples of
potentially protective compounds include titanium oxide, zinc
oxide, and others well-known to those skilled in the art. Examples
of compounds to improve efficacy can include photosensitizers such
as the broad categories of psoralens, the porphyrin family, and
other photosensitizers which are well-known in the art. FIG. 5C
shows a bock diagram of an example of an embodiment of radiation
applicator 500. FIG. 5C includes radiations sources 502a, 502b,
502e, 502f, 502i, and 502j, substrate 504, controller 520, power
source 530, and electrical connections 522 (such as 522a-522t). In
other embodiments, radiation applicator 500 may not have all of the
components associated with FIG. 5C and/or may have other components
in addition to or instead of those associated with FIG. 5C.
[0119] Radiation source(s) 502a, 502e, 502f, 502i, and 502j are
specific ones of, or specific groups of, radiation source(s) 502
(e.g. 502a-502n), which are discussed in conjunction with FIGS. 1
and 5A shown in FIG. 5C. The sets of three dots after radiation
source(s) 502a, 502f, and 502j represent any number of radiations
sources. Although pairs of letters, such as "e" and "f," and "i"
and "j," may represent pairs of consecutive numbers that are
smaller than the number represented by "n," there may be any number
of radiation source(s) between radiation source(s) 502b and 502e,
between radiation source(s) 502f and 502i, and between radiation
source(s) 502j and 502n. Substrate 504 is discussed in conjunction
with FIGS. 1 and 5B and elsewhere. Controller 520 and power source
530 are discussed in conjunction with FIG. 3 and elsewhere.
[0120] Electrical connections 522 (e.g. 522a-522t) are paired with
one another. Each pair completes a circuit between controller 520
and one of radiation source(s) 502 (e.g. 502a-502n). The pattern of
electrical connections 522a-522n is different than electrical
connections 322 (FIG. 3). In this embodiment, each radiation source
or group of radiation source(s) has its own ground or return
electrode and can be controlled independently by controller
520.
[0121] Turning now to FIG. 5D, a close-up of a molded covering 513
with optical components built-in is depicted. In this embodiment,
covering 513 is placed over the radiation source which then resides
in space 522. The covering 513 can be a molded piece, a machined
piece, a lithographically formed piece, or a combination of these.
Angled indent 526 represents a three-dimensional component of the
piece (covering) which is a planned feature of the molded piece.
Layer 524 is an optional layer which can be deposited on the angled
indent 526. Layer 524 can be reflective, refractive, absorbing, or
diffusing, having a different index of refraction from the covering
513 material. Diffuser 528 is another feature which can optionally
be built into the molded covering 513. Diffuser 528 is a feature
adapted and configured to further direct, focus, diffuse, or
otherwise condition the radiation leaving source 502. One or more
projections 530 can be deposited or glued onto covering 513. These
projections 530 can be adapted and configured to enhance heat
transfer, enhance bonding, or enhance conduction to an underlying
mount. Although covering 513 depicts space for only one set of
radiation sources 522, those skilled in the art will recognize that
more than one radiation source or sources can be included in
covering 513.
[0122] FIG. 6A shows a radiation applicator 600. Radiation
applicator 600 includes radiation source(s) 602a-l, substrate 604
having cords 605a-605m, controller 606, and power source 608. In
other embodiments, radiation applicator 600 may not have all of the
components in FIG. 6A or may have other components in addition to,
or instead of, those in FIG. 6A.
[0123] Radiation applicator 600 may be an embodiment of a radiation
applicator. Radiation source(s) 602a-l could be of any of the types
of radiation source(s) as radiation source(s) 602 (e.g. 602a-602n).
Substrate 604 may be a mesh (e.g., a flexible net) that is made of
crisscrossing cords 605a-m, which may be an embodiment of substrate
104 in FIG. 1. For example, the flexible net that makes up
substrate 604 may be a bandage which is highly elastic. Radiation
source(s) 602a-l can be placed at the intersection of individual
cords 605a-m of substrate 604. In an alternative embodiment,
radiation source(s) 602a-602l may be placed on other parts of cords
605a-605m in addition to, or instead of, being placed at the
intersections of two of cords 605a-605m. Controller 620 may be the
same as controller 320 of FIG. 3 and power source 630 may be the
same as power source 330. Cords 605a-m may carry or may include
electrical connections 622 and/or optical fibers that bring
electricity and/or optical communications from controller 606 to
radiation source(s) 602 for powering and/or communicating with
radiations sources 602a-6021. The configuration of cords 605a-605m
allow radiation source(s) 602a-602l to cool by allowing air to pass
across the backs of radiation source(s) 602a-602l. The
configuration further allows for flexible spacing between the
intersections of the cords. In this way, the material (the nodes)
can be spread apart by applying force to the edges of the radiation
applicator 600 and then allowed to return to the prior spacing when
the edges are allowed to return their previous spacing. Although
the embodiment of FIG. 6A does not include a region such as region
106, in an alternative embodiment, substrate 604 may include a
region 606.
[0124] FIG. 6B shows a cross-section of an example of an embodiment
of a radiation applicator 600. The embodiment of FIG. 6B includes
light source 602k, mount 604k, cord 605i, cord 605j, header 606k,
spectral conditioner 612, and optional patient interface 614. In
other embodiments, radiation applicator 600 may not have all of the
components associated with FIG. 6B and/or may have other components
in addition to, or instead of, those associated with FIG. 6B.
[0125] Light source 602k, mount 604k, and header 606kare the light
source, mount, and header of one of radiations sources 602a-602n.
Light source 602k, mount 604k, and header 606kmay be embodiments of
light source 602, mount 614, and header 616, respectively.
Similarly, spectral conditioner 612 and optional patient interface
614, which may include adhesive, may be an embodiment of spectral
conditioner 650 and optional patient interface 612, respectively.
Cords 605i and 605j are two of cords 605a-605l. Cords 605i and 605j
are a pair of cords that criss-cross one another under mount
604k.
[0126] As discussed above, the radiation applicator 600 can be
adapted to be placed on a patient at a target body surface such
that it covers, or substantially covers, a therapeutic surface
area. As shown in FIG. 6C, the radiation applicator 600 is applied
to the target body surface such that the radiation applicator 600
covers a lesion 20, to which therapy will be delivered. Further
radiation sources 602, 602' associated with the radiation
applicator 600 can be selectively activated such that a first
subset of radiation sources (602) is on, while the remainder of the
radiation sources (602') are not on. As illustrated, the first
subset of radiation sources 602 are positioned within the radiation
applicator 600 such that the radiation sources 602 can apply
therapy to the lesion 202. As will be appreciated by those skilled
in the art, the first set of radiation sources 602 can be further
divided into subsets that are separately programmable to deliver
different therapeutic doses. This embodiment would be appropriate
where, for example, a lesion to be treated has, within the lesion,
areas that require more therapeutic treatment than other areas
(e.g., a border region of a lesion might require less therapy, than
a central portion). Radiation applicator 600 may also in-part
comprise detectors that can sense certain physical attributes of a
body surface that may differentiate a therapeutic region and a
non-therapeutic region. The detectors, for example, can define the
region of a lesion such that radiation sources covering the lesion
region will be activated while those not covering the lesion region
will not be activated. The detectors may detect one or more
parameters including, but not limited to: temperature, electrical
impedance, photoreflectance, thickness, hardness, moisture, and
acoustic reflections. Where the detectors measure photoreflectance,
measurements may include one or more of the following: roughness,
color, and fluorescence.
[0127] FIG. 7A shows an embodiment of the therapeutic device 700 in
which radiation sources are incorporated into a device which can be
worn or otherwise fixtured, carried, or attached to a patient while
the therapy to treat a skin disorder is being applied. Although the
device 700 of the embodiment illustrated in FIG. 7B has the form of
a bracelet, the radiation sources 740 can be incorporated into any
material which can at least partially cover or are in direct or
indirect contact with the patient's skin 742. For example, the
therapeutic device 700 may have the form of a bandage, blanket, any
articles of clothing, a ring, jewelry, a hat, a wristband, a shirt,
a sock, underwear, a scarf, a headband, a patch, a gauze pad, or
any other wearable article, etc. The device 700 may be adapted and
configured to communicate with photodetectors, which can
continuously readjust the device's output or can be configured to
detect a disease state of the skin so that the optical therapy can
be applied.
[0128] In another embodiment, several devices 700, 100 (e.g.,
bandages) are brought together or applied to treat a larger area.
In one embodiment, a kit having different sized bandages is
provided. Adhesive can be a component of the kit and/or a component
of the bandages. The individual sized bandages can be fit together
to irradiate different shaped and sized areas or lesions. With such
a "wearable" device 700, a patient can treat his or her disorder
(e.g., psoriasis) while performing other tasks or sleeping and can
treat small or large areas of disease in a time- and cost-effective
manner.
[0129] Such a localized therapy is also safer than treatments which
apply light over a broad area of skin because portions of the skin
which are not psoriatic can be unnecessarily exposed to ultraviolet
light. With the LED systems described above, broad-band or
narrow-band optical therapy can easily be applied to the skin
depending upon clinical requirements. In addition, photodetectors
may be integrated into the therapeutic device 700 for feedback
control of the therapy. Internal body cavities can be treated as
well with permanent or semi-permanent optical therapy devices 700.
For example, in one embodiment, inner ear infections are treated by
placing an optical therapy device 700 inside or proximal to the ear
canal.
[0130] FIG. 7B illustrates an optical therapy device 700 used to
treat fungal infection of the nail beds. In such a case, tinea
infections of the nails may be treated with the device by choosing
appropriate optical wavelengths (e.g., 255-320 nm) for the
radiation sources. The optical therapy device 700 has the form of a
bandage or Band-aid.RTM.. Such a device 700 allows patients to go
about their daily lives while the treatment is being applied. The
device 700 is constructed using the principles and methods
described above. Device 700 can be used in combination with
photosensitizers or photodynamic agents to better treat the
nailbed. In another embodiment, the device shown in FIG. 7B is used
to treat nail psoriasis in which case wavelengths between 295 nm
and 320 nm, typically would be used.
[0131] The devices and radiation source(s) disclosed herein can be
used for therapies such as psoriasis or other skin disorders
currently treated with radiation (e.g., vitiligo, cutaneous T cell
lymphoma, fungal infections, etc.). The preferred action spectrum
to treat psoriasis is approximately 308-311 nm. In addition,
narrow-band radiation is generally more effective than broad-band
radiation. One limiting factor in current modalities and
technologies for the treatment of psoriatic lesions is that typical
devices available on the market today are large and expensive, and
generally require patients to visit a physician's office for
treatment. Home-treatment devices are typically large fluorescent
lamps that are adapted to treat a broad area rather than a
localized region. Whether in the home or in the office of the
medical practitioner, the therapy takes time out of the patient's
daily schedule. In addition, it is typically difficult for a
patient to perform other tasks while the therapy is being applied.
Furthermore, with current technology, it is difficult to treat a
small area of the skin with narrowband light. Lasers are sometimes
used to do so, but lasers are generally expensive and are not
practical as home-based therapy devices.
[0132] As will be appreciated by those skilled in the art, one
challenge of providing uniform illumination to a target body
surface is the high degree of varying curvature of the surface from
location to location on a body. For example, a uniform
approximately planar light source incident upon a flat surface will
provide a uniform intensity distribution across that surface.
However, intensity distribution from the same planar source
incident upon a curved surface can vary greatly as the curved
surface provides in effect a variable degree of distance from the
light source. As depicted in FIG. 8A a light emitting device 800 is
adapted to provide phototherapy to a patient's body. The light
emitting device 800 is a therapeutic treatment apparatus that is
adapted and configured to conform to a target area of a patient's
body. The light emitting device 800 is further comprised of a light
delivery element 804, such as a substrate, that is adapted and
configured to deliver light and that that is flexible and generally
conformable to a target body surface. The light 801 transmitted by
this device 800 is such that its near field optical intensity is
substantially uniformly distributed over the regions emitting
light. The near field optical intensity is here described as the
light intensity that is close to the exit plane a given optical
element. Qualitatively, close in the preceding sentence is defined
as a distance which is small as compared to the size of the optical
element and is concurrently described as the a distance over which
the light intensity does not substantially diminish. Therefore, a
device 800 with these two features provides a uniform
phototherapeutic treatment to virtually any target body surface.
Additionally, the light delivery element 804 should provide a high
degree of wearability for a user at a plurality of locations on the
user's body and the physical dimensions of the light delivery
element 804 are ideally `low profile` such that a thickness of the
device 800 is small compared to its length and width dimensions.
Additionally, the flexibility of the light delivery element 804
facilitates application of the device to a patient while the
patient is in motion (e,g., performing routine daily activities) as
well as delivery of therapy to a patient while the patient is in
motion.
[0133] In the embodiment depicted in FIG. 8A, any suitable light
source 802 can be employed, for example, one or more light emitting
diodes (LEDs), an arc lamp, or one or more laser diodes. The light
source 802 can be adapted and configured to direct light to the
light delivery element 804 which is operated by a controller
element 820 and powered by a power supply 830. The actual
dimensions of a device 800 can be varied within the scope of the
invention and may be dependent upon the particular target body
surface to be subjected to phototherapy as well as to any
portability issues. Additionally, the length, width and depth of a
light delivery element 804 can be varied and may be further
dependent upon the particular target body surface to be subjected
to phototherapy. For example, a device 800 used to treat an area of
the torso is likely to be comparatively larger than a device to
treat an elbow. The light source 802 emits light 801 at a specific
therapeutic wavelength or alternatively within a range of
therapeutic wavelengths to include visible (400-800 nm), infrared
(800-2000 nm), ultraviolet (200-400 nm) light as is suitable for a
particular treatment regimen. For example, ultraviolet light is
used to treat in the wavelength range of 300-320 nm (commonly
referred to as the ultraviolet B range) is typically used for the
treatment of psoriasis. In a typical modern phototherapy treatment,
light with a specific wavelength of 311 nm is used; this is often
referred to as narrow band ultraviolet B therapy.
[0134] In another embodiment, depicted in FIG. 8B, the light
delivery element 804 is directly coupled to a heat absorbing
structure 824 that is typically located on an opposite side to the
side that transmits the treatment light. The heat absorbing
structure 824 is designed such that waste heat created by the
delivery element can be dissipated directly on the device and
therefore substantially allows the light delivery element to remain
at or below typical body surface temperature. However, it may also
be configured such that a small amount of heat, such as a
therapeutic amount, is applied to the target body surface, while
the remaining heat generated is dissipated. In an embodiment, the
heat absorbing structure 824 may be comprised of a bladder 825 that
is filled with a solid, liquid, gas, or mixture thereof that has
suitable heat capacity. For example, 5 watts of power may be
consumed by the delivery device during 10 minutes of operation thus
creating approximately 3000 Joules of heat. To sustain a
temperature rise from ambient (25 C) to body temperature (37 C), it
would be suitable for the bladder to contain at least 63 grams of
water. Additionally, such a bladder may be temporarily removable
such that it may be externally heated or cooled prior to device
operation to then subsequently be affixed in the heat absorbing
structure to provide enhanced heat capacity based upon device use.
In the embodiment depicted in FIG. 8B, any suitable light source
802 which could be one or more LEDs, an arc lamp, or one or more
laser diodes, is directed to the patient interface element 812 and
is operated by a controller element 820 and a power supply 830.
[0135] FIGS. 9A-C depicts several potential examples of typical use
of the described medical device. An essential feature of this
device 900 is that it is wearable. In all examples of FIG. 9, the
light delivery element conforms to the area of treatment and allows
for unencumbered activity by the user. In FIG. 9B, the device is
shown providing therapy over a high curvature, moving joint such as
the knee. The device is also intended for other high curvature yet
static body locations such as a forearm as shown in FIG. 9A.
Additionally, the device 900 can be configured to treat large areas
of relatively lower curvature surfaces such as the front torso, as
depicted in FIG. 9C. However, as will be appreciated by those
skilled in the art, the device can be configured to, for example,
be applied to the lower back, as well as other body surfaces. The
described device 900 can be affixed to a particular area of the
body by any suitable attachment mechanism, such as an adhesive
film, one or more straps, a material over wrap, or a cuff. An
effective application of such attachment mechanism may in turn
facilitate mobility of the patient during treatment thus rendering
the entire device to be wearable. It is understood that a
comfortable therapeutic device could be used on most parts of the
human anatomy. It will be appreciated by those skilled in the art,
that embodiments of the invention can potentially be applied to any
part or surface of the body. For example, a patient with psoriasis
may have areas of the disease on areas of the body, such as a limb,
that have an inherent high degree of surface curvature.
[0136] FIG. 10A describes an embodiment of a flexible, conformal
device 1000 with light sources 1002 are incorporated into a
conforming substrate. The flexible, conformal device 1000 is yet
another embodiment of a therapeutic treatment apparatus. The light
sources 1002 are aligned to provide light 1001 in the direction of
transmission of the delivery element, ostensibly in a direction
towards the body surface. The light sources 1002 can be light
emitting diodes, laser diodes, or any other light source
commensurate or adaptable to the size, shape, and wearability of
the delivery device. The arrangement of light sources is adapted to
provide sufficient light over all areas of the portions of the
device intended to transmit light to a body surface. In some
specific embodiments linear and array-like configurations of light
sources may be used to achieve the light dispersion objective. It
is also possible to arrange the light sources in any other regular
or non-regular pattern such as a circle, where the spacing between
each light source may or may not be equivalent. These light sources
are also operated by a controller element 1020 and a power source
1030. In this embodiment, each light source 1002 will have a light
integrator associated with it that controls the light distribution
onto the target surface.
[0137] FIG. 10B describes an embodiment of a flexible and conformal
therapeutic light delivery device 1000 emitting therapeutic light
1001 with a fiber optic light guide 1026 as an input source from a
fixed external light source 1002. In this embodiment, fibers from
the fiber optic light guide 1026 terminate into light integrators
which control the light distribution onto the target surface. As
with other embodiments, the light source may be an arc lamp, a
laser, a plurality of laser diodes, a plurality of LEDs, or any
other suitable method of generating therapeutic light. As shown,
the light source is operated by a controller element 1020 and a
power supply 1030. In this embodiment, the light generation site is
in a remote location as compared to the light delivery site. This
may be advantageous in view of typical light source inefficiency.
For example, as heat is generated along with light, it is generally
desirable in the therapeutic setting to dissipate heat in and
around the location of light generation. However, by decoupling the
generation of light from the delivery of light, associated
challenges of light delivery along with heat dissipation are also
decoupled and can be addressed separately.
[0138] FIG. 10C illustrates a flexible light delivery device 1000
with one or more light sources 1002 incorporated into the device
1000 and aligned to provide light perpendicular to the direction of
transmission of the delivery element to the target body surface.
The light sources can be a plurality of light emitting diodes, a
plurality of laser diodes, or any other light source commensurate
or adaptable to the size, shape, and wearability of the delivery
device. The light 1001 is distributed onto a target body surface
using light integrators which operate on the optical principles of
reflection or refraction or other suitable optical means. An analog
of this delivery scheme is similar to the backlight of a typical
LCD screen used in portable electronics. These light sources are
operated by a controller element 1020 and a power source 1030. This
embodiment effectively clusters the light sources in a minimum of
distinct locations thus in turn minimizing the extent of electrical
and mechanical connections necessary for their operation.
[0139] FIG. 11 depicts a cross section of an embodiment of a
flexible, conformal light delivery element residing on a plane of
contact 1105. Light sources 1102 and related housings 1104 are
directly disposed on a continuous, optically transmissive material
1106. The distance between the light sources 1102 and the plane of
contact 1105 is distance Y. The material pliancy is driven by both
its thickness and its soft nature, such that it is both conformal
and comfortable when applied to a body surface. For example, this
material should not have a durometer value that exceeds 70 on the
Shore A measurement scale; thus material is typically selected
which has a durometer of less than or equal to Shore 70 A.
Additionally, the material can be at least partially transmissive
to therapeutic light. The light sources 1102 are spaced a distance
X apart in a linear fashion. This concept can be extended to a two
dimensional array with all light sources equidistant from one
another, again at a spacing of X. As a design constraint to enable
the delivery of uniformly distributed light, the spacing X in this
embodiment is less than or equal to thickness Y. This relationship
arises because each light source is considered to be a point
source, or Lambertian, emitter.
[0140] FIG. 12A illustrates a cross sectional view of an
interfacial feature 1208 between the plane of contact 1205 of a
patient and any conformal, flexible light delivery element 1200
described herein. This feature 1208 may be composed of the same
substrate that comprises the light delivery element and is intended
to not disrupt the optical output of the device yet concurrently
provide less than 100% body surface contact between the device and
the patient. This arrangement may be beneficial if, for example,
the target body surface requires ventilation during the duration of
a phototherapy treatment. As is depicted, hemispherical bump
features, of comparably small thickness to that of the delivery
device are located at regularly spaced intervals along the entire
interfacial region. Although bumps are shown, alternative similar
sized features such as ridges or rings may also be employed.
[0141] Another feature depicted in FIG. 12B is the intentional
incorporation of an interfacial material 1209 between the plane of
contact 1205 with a patient and the conformal, flexible light
delivery element 1200. The local irregularity of patient's body
surface may make it favorable to apply a material such as an
optically transmissive gel or emollient to enhance the optical
coupling between the emitting and receiving surfaces.
Alternatively, a disposable film or thin sheet can be placed
between the flexible substrate of the device and the target body
surface. This may be beneficial to keep the therapeutic device
clean of oils, exfoliate, or other material picked up with contact
with the body surface. The disposable thin film is at least
partially transmissive to the therapeutic wavelength as is emitted
from the device.
[0142] FIG. 13A depicts yet another embodiment of the described
invention. A feature of this embodiment is the association of each
light source with an individual, geometrically defined unit cell
1303. The unit cell functions on a defined scale to individually
accomplish the task of the device as a whole; in acting
substantially as a light integrator, each unit cell 1303 is itself
transmitting and distributing light in a substantially uniform
manner from an associated light source. Therefore the unit cells
act as an ensemble to individually deliver substantially uniformly
distributed light as parts of device that conforms to a patient
body surface. The unit cells 1303 as shown are roughly cuboid in
shape but may take other shapes as well. They are affixed as an
ensemble to a unifying flexible substrate 1304. The flexible
substrate may be a rubber material, including natural and synthetic
rubbers, or may be fabric, cloth, thermoplastic, flexible metal,
elastomer, or any combination thereof Alternatively, the flexible
substrate can be formable such that once it is formed in a shape it
will remain substantially in that shape until additional
deformation is applied. Additionally, the light sources 1302 are
operated by a controller 1320 and a power source 1330. In an
embodiment, this controller 1320 is a programmable microprocessor
and the power source 1330 is a battery and both are located either
as a single component or as distinct separate components from the
therapeutic device. In another embodiment, the controller and
battery are integrally mounted to the therapeutic device 1300. In
an embodiment, the unit cell 1303 is in part functioning as a
waveguide.
[0143] FIG. 13B is a cross sectional schematic view of several unit
cells 1303 (depicted without associated light sources) with a
lateral dimension of D and a spacing between each unit cell of a.
For purposes of achieving more uniform light distribution, D is
typically larger than a. For example, D may be 1 cm while a may be
1 mm. A thin layer of flexible material 1304 which acts as a
substrate for the ensemble of unit cell features may also be
provided. The thickness t of this flexible layer 1304 is
comparatively thin, e.g. 1 mm, when compared to the overall
thickness h of the light delivery element, e.g. 1 cm. This provides
the flexibility of the ensemble assembly. The flexible substrate
material 1304 can be a material identical to that substantially
comprising the unit cell, such as silicone rubber, or may be a
separate material as has been previously mentioned. Additionally,
the contact point of the flexible material and the unit cell can be
at any location along height based on suitability for design. As
shown, the cells are connected at the extreme edge of the top of
the cell. However, they could be connected at the lower extreme
edge, or at any location between the edges. In an embodiment, the
unit cell is more rigid than the flexible substrate, based either
entirely on thickness considerations or alternatively based upon
materials selection. Therefore, in this embodiment, the ensemble
device derives its flexibility and conformal nature by combining
semi-rigid though defined unit cell blocks with a flexible
substrate.
[0144] The unit cell 1303 serves several unique, enabling functions
for light distribution. First, light sources 1302 employed in this
particular application, such as LEDs, lasers, or fiber optically
delivered light, can often be considered as point sources of light.
Since the intensity of a point source decreases in a quadratic
fashion with respect to the distance from the emitter, it is
important that the distance from the emitter to the plane of
contact be kept constant. In a semi-rigid unit cell configuration,
each cell will retain its shape when placed in contact with a
curved body surface; therefore, the intended uniform optical
distribution will be retained despite use in a myriad of
configurations and application to surfaces with varied curvature.
For example, a single device could be applied to deliver a
therapeutic treatment at different times to a knee, an elbow, a
calf, and a region of the lower back without any substantial
alteration to its form or functionality. Secondly, geometrically
defining each unit cell by essentially giving it sidewall features
enables the bulk of each unit cell to act as an optical integration
unit. Internal reflection caused by at least a partially
transmissive coating or other mechanism at the wall boundary can
act to redistribute incident light as it is on the path towards the
target plane of contact with the body surface. A method of
reflection is known as total internal reflection, and is caused by
a contrast in the index of refraction between the material
comprising the light integrator and air. This reflection phenomenon
at the unit cell wall boundary will can cause redistribution of
transmitted light at the plane of contact of such a unit cell.
These effects can advantageously compensate for the typical
aforementioned spatial decrease in light intensity with respect to
the distance from the light source. It is important to note that
some internal reflection does not disallow some therapeutic light
from exiting the light integrator element at any point along the
sidewall feature. This characteristic can in fact enable light to
reach areas of a body surface that are not in close contact with a
light integrator element, such as the finite space in between unit
cell structures.
[0145] A generalized picture of the unit cell is shown in FIG. 14A.
The unit cell is adapted and configured to form a therapeutic
treatment apparatus. In this embodiment, the device or apparatus is
comprised of three building blocks. The first building block is the
light integration unit 1404 which typically is positioned on the
plane of contact 1405 with a target portion of a body surface. A
key material property necessary for this light integration unit is
that it be at least partially optically transparent to the desired
range of wavelengths used in the specific phototherapy treatment.
Additionally, this material should be rigid or semi-rigid. The most
desirable material for this application is an acrylic or a silicone
elastomer, while epoxy, polycarbonate, fused silica, and
combinations thereof may be used. Second, a light source 1402 and
light source housing 1414 are described. As is shown, these
features are located above the light integration unit. The light
source housing is generalized to include any combination of
relevant componentry such as device packaging materials and
components, electrical contacts, a circuit board, or a flexible
conductor. An optical element 1450 which functions to aid in the
distribution of the light emitted from the light source 1402 may
also be provided. This element 1450 can be a convex, concave,
aspheric, diffractive, Fresnel type, or free form lens. It is also
possible to incorporate this optical element 1450 directly into the
light integration unit 1404 by molding or any other mechanism as
well as it is possible to integrate this optical element 1450
directly into the light source housing 1414 feature. An alternative
embodiment does not make use of a specific intermediary optical
element.
[0146] Applications may dictate the formation of various prism
shapes of the light integration unit that are not specifically a
cuboid geometry with right angles. A cuboid is defined here as an
elemental shape composed of six nearly rectangular sides. FIG. 14B
is a cross sectional representation of an embodiment of a unit cell
structure with light source 1402 and light source housing 1414,
optical element 1450, and a light integration unit 1404. The light
integration unit is typically positioned on the plane of contact
1405 with a body surface and has a roughly trapezoidal shape
characterized by defining an angle of a of the lower corner
vertices 1452. These unit cell shapes may be thus optimized to
enhance distribution of transmitted light to a body surface. The
angle a may be selected from a range between 5 and 90 degrees.
Additionally, this angle may describe the lower corner vertices of
other geometric shapes comprising the unit cell element such as a
pyramid or a hexagonal prism.
[0147] FIG. 14C is a cross sectional representation of an
embodiment of a unit cell structure with light source 1402 and
light source housing 1414, optical element 1450, and a light
integration unit 1404 which is typically positioned on the plane of
contact 1405 with a body surface. In this embodiment, the specific
cross sectional geometry of the light integration unit is described
by a height h, a variable lateral dimension b, a variable vertical
dimension c, and a radius of curvature r describing the shape's
edges at the plane of contact with a body surface. In one
embodiment, the value of r is equal to h and the value of c and b
are zero such that the form of the light integration element is
hemispherical. In another embodiment, the values of b and c are
equivalent and nonzero and therefore for a given value of r, the
geometric form of the light integration element resembles a
structure similar to a cube with the corners and edges nearer the
plane of contact with the body surfaces taking on a rounded
character. In yet another embodiment, the value of b and c are not
equal yet are nonzero and therefore for given values of r, the
geometric form of the light integration element resembles a
structure similar to a rectangular prism with the corners and edges
nearer the plane of contact with the body surface taking on a
rounded character. For example, r may have a value ranging from 0.5
mm at a minimum to the value of h at a maximum. In another example,
r can have a value ranging from 0.5 mm to 25 cm and is not
constrained to a maximum of the value of h.
[0148] FIGS. 15A-C offers a schematic, plan view of several
embodiments of particular individual unit cell geometry. FIG. 15A
shows a representation of the aforementioned cuboid geometry, here
depicted as a series of square shapes. FIGS. 15B-C further
demonstrates respectively triangular and hexagonal shapes that can
be employed. In all cases, each side of the unit cell is a length D
with each unit cell being separated by a spacing a, and the
placement of each shape is intended to efficiently incorporate
these shapes such that the length D is considered large as compared
to spacing a. Therefore the intention is to closely approximate a
`close packed` shape configuration, regardless of actual repeated
shape used. For example, considering a cylindrical unit cell (not
shown), the measurement D would alternatively describe the diameter
of the unit cell.
[0149] In one embodiment, the selection of the size of each unit
cell, represented here and earlier as length D, follows a specific
design rule based upon the radius of curvature of a particular body
surface that the light emitting element is applied to as well as
the tolerance for deformation of a particular body surface. This
situation is schematically represented by FIG. 16 where
representative cross sectional unit cells 1603 are applied to a
surface with a radius of curvature R. The goal of the device is to
conform to a body surface using this unique unit cell approach to
practically deliver uniformly distributed light. Therefore, maximum
contact of the distal end of each unit cell with a particular body
surface is desired and considered important in achieving this goal.
Therefore, an allowable deformation by the unit cell structures of
the typically relatively soft skin surface of a patient's body is
referred to as distance d and is also included in this FIG. 15. An
inset to FIG. 15 includes the geometric solution to find an
expression for D in terms of the known quantities d and R.
Symbolically, D=2 {square root over (2dR-d.sup.2)}. These design
criteria allows for customization of either individual or a range
of light delivery devices with respect to particularly dissimilar
body surfaces. Alternatively, the device is applied to a rigid body
surface such that no value of deformation, d, is allowed. The
distance d thus theoretically represents the maximum separation
between the bottom plane of a unit cell structure and a body
surface. In this case, in order to maintain a uniform light
distribution delivered to a body surface, a range of values for D
can be selected such that for a given radius of curvature, R, the
value d remains small as compared to D. In practical application, D
may be less than 5 cm.
[0150] FIG. 17A is a cross sectional representation of an
embodiment of a unit cell structure with light source 1702 and
light source housing 1714, optical element 1750, and a light
integration unit 1704. In this embodiment, the light integration
structure is composed of two distinct materials, with a first one
1751 immediately disposed below the optical element and the second
material 1751' substantially located at the plane of contact with a
body surface. One aspect of this embodiment is to create an index
of refraction contrast by joining two dissimilar materials. The
interface between two materials of dissimilar indices of refraction
can present an opportunity to shape and otherwise condition light
transmitting from one material to the other. Therefore, the
distribution and therefore uniformity of the transmitted
therapeutic light can be affected in a way beneficial to the
therapeutic treatment. Various shapes and quantities of these two
materials that differ from what is schematically depicted can be
employed in keeping with the original description.
[0151] Further, an alternative configuration of the above concept
is described. FIG. 17B is a cross sectional representation of an
embodiment of a unit cell structure with light source/light source
housing 1714, and optical element 1750 and a light integration unit
1704. In this embodiment, the light integration structure is
composed of two distinct materials, with a first material 1704'
entirely surrounding the second material 1704''. The interface
between two materials of dissimilar indices of refraction can
present an opportunity to shape and otherwise condition light
transmitting from one material to the other. Therefore, the
distribution and therefore uniformity of the transmitted
therapeutic light can be affected in a way beneficial to the
therapeutic treatment. For example, the second material can be air.
One aspect of this configuration can offer the advantage reduced
transmission losses through the optical integrator medium while
still. A second aspect of this configuration is that it can offer
several material interfaces with which to shape and otherwise
condition transmitted light. Various shapes and quantities of these
two materials that differ from what is schematically depicted can
be implemented in accordance with the above description.
[0152] FIG. 17C is a cross sectional representation of an
embodiment of a unit cell structure with light source 1702 and
light source housing 1714 and optical element 1750. Physical
support is provided by a supporting wall structure 1754 which
contacts the light source housing as well as the plane of contact
with the body surface 20. This supporting wall structure may be
coated with a material 1756 that is at least partially reflective.
Alternatively, the optical properties of the supporting material
are such that uniform light distribution is achieved by making use
of physical phenomena including but not limited to total internal
reflection. This supporting element may be made of metal, an
elastomer, an acrylic, fused silica, a combination of any of the
above or any other suitable material or combination of materials.
As opposed to the above designs, this particular structure does not
explicitly provide a solid material light integrator as part of the
unit cell. However, the above structures can function in
conjunction to provide a similar ability to distribute light
uniformly to a contacted body surface. It an embodiment, it is
intended that these support structures make contact with 15% or
less of the body surface receiving the therapeutic treatment.
Optical element 1750 functions to aid in the distribution of the
light emitted from the light source 1702. This optical element 1750
may be a convex, concave, aspheric, diffractive, Fresnel type, or
free form lens. It is also possible to incorporate this optical
element 1750 directly into the light source housing 1714 feature.
An alternative embodiment does not make use of a specific
intermediary optical element.
[0153] FIG. 17D is a cross sectional representation of an
embodiment of a unit cell structure with light sources 1702 and a
light source housing 1714. Physical support is provided by a
supporting wall structure 1754 which contacts the light source
housing 1714 as well as the plane of contact with the body surface
20. This supporting wall structure may be coated with a material
1756 that is at least partially reflective. In this embodiment, one
or more light sources 1702 are permanently positioned at one or
more predetermined angles with respect to the plane of contact with
the body surface 20 to emit light such that a substantially uniform
distribution of light is transmitted to the body surface at the
plane of contact with the cell support structure.
[0154] FIG. 17E is a cross sectional representation of an
embodiment of a unit cell structure with light source 1702, light
source housing 1714, and optical element 1750. Physical support is
provided by a supporting wall structure 1754 which contacts the
light source housing 1714 as well as the plane of contact with the
body surface 20. This supporting wall structure 1754 may be coated
with a material 1756 that is at least partially reflective.
Additionally, select surfaces of the light source housing 1714 may
also be coated with a material that is at least partially
reflective. In this embodiment, the optical element 1750 is located
at the distal end of the unit cell in close proximity to the plane
of contact of the body surface. This optical element 1750 may be a
converging, diverging, aspheric, diffractive, fresnel type, or free
form lens, but may also be a filter, diffuser, or body which
otherwise conditions the light.
[0155] FIG. 18A depicts a light source 1802 and associated light
source housing 1814 that has been described in the preceding text.
This light source may be a semiconductor diode such as an LED or
laser diode and its associated packaging. The housing serves to
provide mechanical support to the light source. The light source is
attached to the light source housing by any number of suitable
mechanisms that may include solder, epoxy, ultrasonic bonding,
thermal paste, or any combination thereof. The housing 1814 can
also substantially comprise a printed circuit board to provide
electrical connection to the semiconductor light source. As
discussed previously, this light source housing can be mounted in
or on a flexible substrate. This could include being molded-into
the substrate or being separately attached in any other desired
manner.
[0156] FIG. 18B depicts a light source and light source housing
that has been described in the preceding text. In this embodiment,
the light source is an optical fiber 1811 or group of optical
fibers (not shown) which terminate in the vicinity of a specialized
housing 1814. In this configuration, the fiber communicates light
which is generated from a light source or group of light sources
that are located separately. An advantage of this scheme is such
that it can reduce the complexity of the device by effectively
reducing the number of associated light sources. A support
structure 1858 is provided for routing and aligning an optical
fiber and for mechanical integrity. The optical fiber(s) 1811 as
shown to be positioned horizontal to the body surface, but can be
oriented in alternative ways as well. Not depicted are any number
of optional optical elements that can be incorporated into the
device to direct the light emitted from the terminating optical
fiber. As will be appreciated by those skilled in the art, optical
elements that direct light emitted from an optical fiber can be
incorporated into the design of the device without departing from
the scope of the invention. For example, a reflective surface such
as a mirror can be positioned to direct emitted light in a
substantially different dissimilar direction with respect to the
orientation of the terminating fiber. The various schemes presented
for an optical integrator also can be applied to this embodiment,
where the optical fiber or fibers terminates into the optical
integrator.
[0157] FIG. 19A depicts a variation on a light housing/light source
element for a semiconductor diode light source. A heat sink element
1960 comprising a flat thermally conductive material is attached
via solder, thermal paste, epoxy, ultrasonic bonding, or other
compatible mechanism, to the light source housing and may
alternatively be considered to be part of the light source housing
1914. In this embodiment, there exists a direct thermal path from
the semiconductor diode light source 1902 to this heat sink element
1960. As will be appreciated by those skilled in the art, the heat
sink 1960 can be exposed to air to maximize its exposure for
convective heat transfer and thus enhanced thermal dissipation. The
heat sink 1960 may be comprised of a metal, a ceramic, a polymer,
an inorganic material such as graphite, or any combination
thereof.
[0158] FIG. 19B depicts an alternative embodiment of a light
housing 1914' for a semiconductor diode light source 1902'. A heat
sink reservoir 1960' may be enclosed by a support structure 1904'.
In this embodiment, there exists a direct thermal path from the
semiconductor diode light source 1902' to this heat sink reservoir
1960'. The heat sink reservoir 1960 is considered to have
sufficient heat capacity to absorb the heat generated during the
operation of a semiconductor diode light source 1902' during an
application of phototherapy. As is depicted, heat sink reservoir
1960' can consist of a conventional heat absorbing material with
significant heat capacity such as water. Alternatively, this
material can be a phase change material such as a salt hydride or
paraffin. The essential property of such a material is that it
typically can absorb a relatively significant amount of heat, for
example at a temperature equivalent to its melting point, before
releasing the energy in the form of a phase change. Preferably,
this phase change would occur at or around body temperature of
approximately 37 C. Alternatively, the heat sink reservoir 1960' is
composed of a metal such as copper or aluminum.
[0159] An applied concept for the described device in all of its
embodiments is the use of this device alongside a targeting method.
Typically, areas of a patients body surface in need of phototherapy
are of varying shape and size; therefore, rather than custom
manufacture light delivery units to conform to these sizes, an
intermediate separate object can be arranged to only expose desired
areas to the treatment light.
[0160] FIG. 20A shows an exploded view of the basic components of
one embodiment of this concept. An affected area 21 on a patient's
body surface 20 is of an arbitrary shape. A separate targeting mask
2040 may be a continuous light absorbing material with a
predetermined `window` area that is reasonably identical to the
shape and size of the prescribed area on the patient's body
surface. This mask can be have an adhesive coating on one or more
sides to adhere to the patient body surface, the light delivery
device, or both. Other mechanisms are possible to attach the mask
to the target surface including, but not limited to, straps or an
elastic grip. Alternatively, the mask can be attached directly to
the therapeutic device or can be considered part of the therapeutic
device. This mask can for example be constructed from a flexible
material such as cloth, an elastomer, foam, a non-woven synthetic,
or other suitable material and is 0.1 to 5 mm in thickness, but
preferably 0.5 to 2 mm in thickness. A light delivery device 2000
that is flexible and conformal to a patient body surface 20 and is
attached to a light source 2002, controller 2020, and power source
2030 is depicted and intended to be used in concert with the
targeting mask.
[0161] FIG. 20B illustrates a collapsed, `in service` view of the
targeting element 2040 in between the delivery device 2000 and the
patient body surface 20. In this depiction, the mask element is in
intimate contact with the light delivery device and the patient
body surface. It is important to note that the lateral dimensions
of the targeting mask can be larger than the light delivery device
to ensure that therapeutic light does not reach the patient body
surface beyond the mask borders. In an embodiment, the mask can
extend far beyond the periphery of the light delivery device to an
extent that it can be contiguous over a certain part of an
extremity. For example, the mask could wrap entirely around an arm
and be secured in a similar fashion to that of a typical wristband
or elbow brace. In an alternative embodiment, the mask material can
be made up of a gel, liquid, aqueous or oil based suspension, or
other physically or chemically blocking material that would at
least partially absorb incident therapeutic light. In this
embodiment, the mask material would selectively be applied to areas
of a body surface which are desired to either receive either a zero
amount or alternatively a substantially reduced amount of
therapeutic light as compared to a desired treatment location such
as an affected area. The light delivery device 2000 is attached to
a light source 2002, controller 2020, and power source 2030 is also
depicted.
[0162] FIG. 21A depicts the features of an embodiment of a masking
element 2140. Chief among these features is a well defined light
transmissive region 2106 that is at least partially transmissive to
light. The mask may include a border region 2110 which is the area
surrounding this transmissive region, of a lateral dimension p into
its exterior periphery. This border region 2110 may extend for a
distance of 0.0 to 10 mm but more preferably 2-5 mm. The remaining
portion of the masking element can be composed of a material which
is absorbing to the light emitted by the associated phototherapy
device.
[0163] FIG. 21B is a cross sectional schematic view of a light
delivery device 2100 emitting treatment light 2101 with a
representative masking element 2140 between this device and a body
surface (not shown). The light transmissive region 2106 may have no
physical material presence thus theoretically allowing 100%
transmission or may be a distinct material which is at least
partially transmissive to the therapeutic light. In the latter
case, this material may be a silicone elastomer, an acrylic,
polycarbonate, or other suitably light transmissive material.
[0164] FIG. 21C is cross sectional schematic view of a light
delivery device 2100 emitting treatment light 2101 with a
representative masking element 2140 between this device and a body
surface. Feature 2110 is a border region which has distinctly
reduced transmission, such as a range of 10%-90% or alternatively,
30%-60%, of that of the specifically defined light transmission
region 2106. This feature is to reduce the overall phototherapy
dose delivered in and around the borders of the affected area to be
treated.
[0165] An alternative embodiment of an applied concept for
delivering targeted phototherapy is depicted in FIG. 22. This
embodiment consists of a flexible and conformal light delivery
element 2204 that is emitting therapeutic light 2201, and a light
source 2202 that is connected to a controller 2120 and a power
supply 2130. The controller 2120 is also connected to a flexible
and conformal masking element 2245 that is essentially an
externally programmable membrane. This membrane functions similar
to that of a liquid crystal display that is able to, in a pixilated
and patterned fashion, selectively at least partially block or
transmit light emitted from the light delivery device. In an
embodiment, as is depicted, the pattern of such selectivity closely
matches that of the affected area 21 on a patient body surface 20
that requires phototherapy. This registry can be programmed in
advance or can be generated by active sensors in this mask element
after placement on the surface to be treated but prior to actual
phototherapy application.
[0166] In one embodiment, the radiation devices are light emitting
diodes (LEDs) and the material between the LEDs and the covering
which interfaces with the body surface is transparent to the light
emitted from the LEDs. In one embodiment, the LEDs emit ultraviolet
light in the wavelength range 200-400 nm. In another embodiment,
the LEDs emit visible light in the wavelength range of 400-800 nm.
In another embodiment, the LEDs emit infrared light in the
wavelength range of 800-2000 nm. The LEDs are chips which are then
assembled into modules, or light sources, which can be manipulated
into a larger device. FIG. 23 depicts a radiation source 2300 which
consists of LED chips 2305, a chip covering or encapsulant 2315, a
chip submount 2325 and a base platform 2335.
[0167] The base platform 2335 can be produced from a substance with
a thermal conductivity to efficiently conduct heat that may be
generated by the LEDs during operation away from the LED devices
and, by association, a patient's body surface. The base can be
microfabricated, molded, machined, or otherwise produced by
techniques well known to those skilled in the art. The base can
further be shaped to conduct heat in an optimal manner. For
example, fins 2340 can be fabricated, deposited, or mechanically or
otherwise attached onto the base platform. In another embodiment, a
thermoelectric cooler is attached to the base platform. The base
can further be processed such that it may become a component in a
circuit on the irradiating device 100. In an embodiment, the
substrate of the radiative device 100 is made so that the base (and
module) can easily press-fit into the radiating device. The
portable irradiating device then has contacts thereon which provide
for electrical communication between the controller and the module
2300.
[0168] Covering 2315 is made from a material transparent to the
radiation emitted from the device. In the case where the chips 2305
emit ultraviolet radiation, the covering 2315 can be produced from
a material such as silicone, fluorinated-ethylene propylene (FEP),
fused silica, or other suitably light transmissive material. It is
preferable that the covering 2315 be of a similar index of
refraction as compared to that of the semiconductor chip (as
described in Example 3, above), so as to minimize reflection at the
interface of the two materials. Covering 2315 can further contain
additional interfaces which serve to condition the light as it is
emitted from the semiconductor material. In an embodiment, the LED
is an ultraviolet LED which emits light from a surface with
dimension of about 1 square mm or smaller. The covering conditions
the light so that the light is distributed over an area of at least
1 cm.sup.2 from the mount 2325. In another embodiment, the covering
conditions the light so that the light is distributed over an area
of between 0.4 cm.sup.2 and 1 cm.sup.2 from the smaller mount. In
another embodiment, the covering conditions the light such that the
light is distributed to an area less than 4 cm.sup.2. In yet
another embodiment, the covering conditions the light to spread
over an area greater than 1 cm.sup.2. The conditioned light may be
distributed in a uniform fashion or may be distributed in a desired
pattern. When 1-2 cm.sup.2 (for example) is used, the covering 2315
can diffuse light from a mount less than about 1-3 mm.sup.2 to a
region 1-2 cm.sup.2 over a distance of between 0.5 and about 5 mm
(the distance between the LED devices and the skin).
EXAMPLE 1
[0169] A ray tracing calculation was performed to show the effect
of a light integrator on the uniformity of the output power at the
exit plane of the device.
[0170] The resulting output of four LED emitters to a flat body
surface was simulated. The four LEDs are positioned on a square
grid with an 11.5 mm spacing between the centers of each LED. The
distance to the body surface is 5.5 mm. The integrators consist of
silicone rubber geometrical shapes that are approximately cuboid in
structure with rounded edges and corners. For simulation purposes,
the refractive index of such transparent structures was set to 1.5.
The size of the integrators is 10.times.10.times.4 millimeters, and
the edges are rounded with a radius of 1 mm. There is a negative
lens incorporated into the top side of the integrator element which
faces towards each respective LED. The radius of this lens is 1 mm.
A schematic diagram from an approximately 3/4 viewpoint is depicted
in FIG. 24. The LED's are assumed to be Lambertian emitters with a
surface area of 0.35 mm.times.0.35 mm. The ray tracing software
(TracePro, Lambda Research Corporation) simulated two distinct
models. The resultant simulated optical intensity distribution
profile at the exit plane of the integrator element is depicted in
FIG. 25A. A second case without the integrator structures present,
though otherwise identical, is depicted in FIG. 25B. A relative
intensity scale is also included. The use of light integrator
elements, as provided for in FIG. 25A, improves the light
distribution intensity profile. Additionally, as will be
appreciated by those skilled in the art, optimization of the shape
of the light integrators can be modified to further achieve an even
flatter distribution profile for the device.
[0171] A variety of kits are also contemplated for use with this
invention. For example, patients could be provided with kits that
have a plurality of radiation applicators with different sizes and
shapes and in which each size and shape can be fit together. The
applicators could be configured to provide the same radiation for
the same amount of time, or could be applicators having different
radiation types and/or amounts and/or time configurations. The
applicators can be fit together and then further adapted to
communicate with a computer program to customize the type, quality,
quantity and/or location of treatment to a pre-defined region. For
example, where it would be desirable to provide a first quality of
treatment at a first time and a second quality of treatment at a
second time, or where it is anticipated that the amount of
radiation and/or time of radiation required would change during the
course of delivering the therapy. Thus, for example, a first
radiation applicator having the ability to deliver a first amount
of radiation at a first amount of time, could be provided with a
second radiation applicator having the ability to deliver a second
amount of radiation for a second amount of time. Thus enabling a
kit to be provided that has the ability to slowly increase therapy
over time, increase and then decrease therapy over time, or
decrease therapy over time.
[0172] As will be appreciated by those skilled in the art, a
variety of methods can be employed to treat a prescribed area of a
target body surface with phototherapy. In one such embodiment, a
prescribed area is treated by: a) applying a light therapy device
adapted to conform to the target body surface; (b) selectively
delivering a therapeutic dose of light to at least a portion of the
target body surface. This method can used for a variety of
dermatological treatments including, but not limited to, the
following: psoriasis, vitiligo, atopic dermatitis, infection, sun
tanning, acne, skin cancer, actinic keratosis, hair removal, dermal
vascular lesions and pigmentation, skin rejuvenation, and
bilirubin. Another embodiment is the use of this phototherapy with
a photosensitizer, where the treatment method includes: (a)
administering a photosensitizer to the patient; (b) applying a
light therapy device adapted to conform to the target body surface;
(c) delivering a therapeutic dose of light to at least a portion of
the target body surface.
[0173] In another embodiment, a prescribed area is treated by: a)
applying a light therapy device adapted to conform to the target
body surface and comprising a plurality of light sources; (b) using
a detector to determine the presence of target tissue; (c)
activating one or more of the light sources to the target tissue to
deliver a therapeutic dose of light. In this embodiment, the
detector detects one or more of the following skin characteristics:
temperature, electrical impedance, photoreflectance, thickness,
hardness, moisture, and acoustic reflections. In this embodiment,
photoreflectance measures one of roughness, color, or
fluorescence.
[0174] In yet another embodiment, a prescribed area is treated by:
a) applying a targeting mask to the target body surface; (b)
applying a light therapy device adapted to conform to the target
body surface and at least partially coupled to the targeting mask;
(c) delivering a therapeutic dose of light to at least a portion of
the target body surface through the targeting mask. In yet another
embodiment, a prescribed area is treated by: a) applying a
substance to a non-prescribed region of the body surface which at
least partially blocks therapeutic light; (b) applying a light
therapy device to the prescribed region and at least partially to
the non-prescribed region, the device being adapted to conform to
the target body surface; (c) delivering a therapeutic dose of light
to at least a portion of the prescribed region. In this embodiment,
the light blocking substance is one of a cream, lotion, gel,
ointment, paste or fluid.
[0175] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *